Oral health interventions for older people in residential aged care facilities: a protocol for a realist systematic review.

INTRODUCTION: Poor oral health among older people is a global problem impacting on health and well-being. The economic cost to the health system is significant. An ageing population is intensifying the urgency for action. However, poor oral health, particularly for those in residential aged care facilities, continues to be highly resistant to resolution. The overall aims of this realist review are to: (A) explore and synthesise evidence on oral health interventions for older people in residential aged care facilities, (B) produce a causal theory on how contextual factors and mechanisms interact to produce outcomes, and (C) produce guidelines/policies to inform high-quality oral health interventions to improve older people's oral health in residential aged care facilities. METHODS AND ANALYSIS: The review is guided by the RAMESES publication standards for realist synthesis. Participants include older people in residential aged care facilities, the aged care workforce, carers and families. Interventions include oral healthcare, oral health education, policy interventions and oral health promotion. The five-step realist review process of Pawson et al will guide the review: clarification of scope and development of initial framework, systematic searches, study appraisal and data extraction, synthesising evidence, drawing conclusions, and dissemination, implementation and evaluation. Expert input with key stakeholders will occur through a blog. Stakeholders will examine consistencies across studies and an explanatory causal theory will be developed to guide policy and practice. ETHICS AND DISSEMINATION: Formal ethical approval was granted by the La Trobe University Ethics Committee HREC 20144. The developed theory will guide education, practice and policy decisions about interventions and the factors that impact on implementation. Using an integrated knowledge translation approach, traditional research outputs such as international conference presentations and publications will be supplemented with stakeholder forums, infographics, blogs, social media postings, webinars, podcasts and writing for web-based independent outlets. PROSPERO REGISTRATION NUMBER: CRD42021155658.

Archetypal meanings of being a paramedic: A hermeneutic review.

BACKGROUND: Interpretations of being a paramedic are normally unspoken in the literature and easily overlooked in the busyness of everyday work. The premise of this study was to explicate historical and cultural archetypes of the paramedic from within relevant literature. METHODS: A hermeneutic review was conducted to explore meanings associated with being a paramedic. This was a novel approach to exploring meanings of being and provided a rich depiction of the cultural and historical nuances inherent in paramedic work. RESULTS: Six paramedic archetypes were identified and related broadly to the principles of service, care and stoicism. These archetypes provided glimpses of how the paramedic is theorised both within and external to the profession, as well as gaps related to how the phenomenon of being a paramedic is experienced amid everyday practice situations. CONCLUSION: Historical archetypes of the paramedic need to be recognised by paramedics as important in shaping the inherited cultural meanings of the work they do. However, due to the limited ability of fixed archetypes to capture the dynamic meanings of being a paramedic further research is required to understand how paramedics experience their caring work as meaningful across diverse contexts.

WITHDRAWN: Extraction of primary (baby) teeth for unerupted palatally displaced permanent canine teeth in children.

BACKGROUND: The permanent canine tooth in the maxillary (upper) jaw sometimes does not erupt into the mouth correctly. In about 1% to 3% of the population these teeth will be diverted into the roof of the mouth (palatally). It has been suggested that if the primary canine is removed at the right time this palatal eruption might be avoided. This is an update of a Cochrane review first published in 2009. OBJECTIVES: To evaluate the effect of extracting the primary maxillary canine on the eruption of the palatally ectopic maxillary permanent canine. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 20 April 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 1), MEDLINE via OVID (1946 to 20 April 2012) and EMBASE via OVID (1980 to 20 April 2012). There were no restrictions regarding language or date of publication. SELECTION CRITERIA: Trials were selected if they met the following criteria: a randomised or quasi-randomised controlled trial, involving the extraction of the deciduous maxillary canine and assessing eruption/non-eruption of the palatally displaced maxillary permanent canine. DATA COLLECTION AND ANALYSIS: Data extraction was undertaken independently by two review authors. The primary outcome was the reported prevalence of eruption or non-eruption of the ectopic permanent canine into the mouth following observation or intervention. Results were to be expressed as risk ratios for dichotomous outcomes with 95% confidence intervals and mean differences for continuous outcomes. Heterogeneity was to be investigated, including both clinical and methodological factors. Authors of trials were contacted to request unpublished data. MAIN RESULTS: Reports of two randomised controlled trials previously excluded from an earlier version of the review due to "deficiencies in reporting, insufficient data" have now been included. These two trials included approximately 128 children, with more than 150 palatally displaced canine teeth, and both were conducted by the same research group. Data presented in the trial reports are either incomplete or inconsistent. Both trials are at high risk of bias. It must be emphasised that both trials have serious deficiencies in the way they were designed, conducted, and reported, and attempts to contact the authors to obtain detailed information and clarify inconsistencies have been unsuccessful. Allocation to treatment appears to be at the level of the individual, but outcomes of successful treatment relate to included teeth and data are not reported for each treatment group. Adverse effects are not reported. Neither trial provides any evidence to guide clinical decision making. AUTHORS' CONCLUSIONS: There is currently no evidence of the effects of extraction of primary canine teeth in 10-13 year old children with one or two palatally displaced permanent canine teeth.

Oral hygiene care for critically ill patients to prevent ventilator-associated pneumonia.

BACKGROUND: Ventilator-associated pneumonia (VAP) is defined as pneumonia developing in people who have received mechanical ventilation for at least 48 hours. VAP is a potentially serious complication in these patients who are already critically ill. Oral hygiene care (OHC), using either a mouthrinse, gel, toothbrush, or combination, together with aspiration of secretions, may reduce the risk of VAP in these patients. OBJECTIVES: To assess the effects of oral hygiene care on incidence of ventilator-associated pneumonia in critically ill patients receiving mechanical ventilation in hospital intensive care units (ICUs). SEARCH METHODS: We searched the following electronic databases: Cochrane Oral Health's Trials Register (to 17 December 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, 2015, Issue 11), MEDLINE Ovid (1946 to 17 December 2015), Embase Ovid (1980 to 17 December 2015), LILACS BIREME Virtual Health Library (1982 to 17 December 2015), CINAHL EBSCO (1937 to 17 December 2016), Chinese Biomedical Literature Database (1978 to 14 January 2013), China National Knowledge Infrastructure (1994 to 14 January 2013), Wan Fang Database (January 1984 to 14 January 2013) and VIP Database (January 2012 to 4 May 2016). We searched ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform for ongoing trials to 17 December 2015. We placed no restrictions on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the effects of OHC (mouthrinse, swab, toothbrush or combination) in critically ill patients receiving mechanical ventilation for at least 48 hours. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed search results, extracted data and assessed risk of bias in included studies. We contacted study authors for additional information. We pooled data from trials with similar interventions and outcomes. We reported risk ratio (RR) for dichotomous outcomes and mean difference (MD) for continuous outcomes, using random-effects models unless there were fewer than four studies. MAIN RESULTS: We included 38 RCTs (6016 participants). There were four main comparisons: chlorhexidine (CHX) mouthrinse or gel versus placebo/usual care; toothbrushing versus no toothbrushing; powered versus manual toothbrushing; and comparisons of oral care solutions. We assessed the overall risk of bias as low in five trials (13%), high in 26 trials (68%), and unclear in seven trials (18%). We did not consider the risk of bias to be serious when assessing the quality of evidence (GRADE) for VAP incidence, but we downgraded other outcomes for risk of bias.High quality evidence from 18 RCTs (2451 participants, 86% adults) shows that CHX mouthrinse or gel, as part of OHC, reduces the risk of VAP compared to placebo or usual care from 25% to about 19% (RR 0.74, 95% confidence intervals (CI) 0.61 to 0.89, P = 0.002, I2 = 31%). This is equivalent to a number needed to treat for an additional beneficial outcome (NNTB) of 17 (95% CI 10 to 33), which indicates that for every 17 ventilated patients in intensive care receiving OHC including chlorhexidine, one outcome of VAP would be prevented. There is no evidence of a difference between CHX and placebo/usual care for the outcomes of mortality (RR 1.09, 95% CI 0.96 to 1.23, P = 0.18, I2 = 0%, 15 RCTs, 2163 participants, moderate quality evidence), duration of mechanical ventilation (MD -0.09 days, 95% CI -1.73 to 1.55 days, P = 0.91, I2 = 36%, five RCTs, 800 participants, low quality evidence), or duration of intensive care unit (ICU) stay (MD 0.21 days, 95% CI -1.48 to 1.89 days, P = 0.81, I2 = 9%, six RCTs, 833 participants, moderate quality evidence). There is insufficient evidence to determine the effect of CHX on duration of systemic antibiotics, oral health indices, caregivers' preferences or cost. Only two studies reported any adverse effects, and these were mild with similar frequency in CHX and control groups.We are uncertain as to the effects of toothbrushing (± antiseptics) on the outcomes of VAP (RR 0.69, 95% CI 0.44 to 1.09, P = 0.11, I2 = 64%, five RCTs, 889 participants, very low quality evidence) and mortality (RR 0.87, 95% CI 0.70 to 1.09, P = 0.24, I2 = 0%, five RCTs, 889 participants, low quality evidence) compared to OHC without toothbrushing (± antiseptics). There is insufficient evidence to determine whether toothbrushing affects duration of mechanical ventilation, duration of ICU stay, use of systemic antibiotics, oral health indices, adverse effects, caregivers' preferences or cost.Only one trial (78 participants) compared use of a powered toothbrush with a manual toothbrush, providing insufficient evidence to determine the effect on any of the outcomes of this review.Fifteen trials compared various other oral care solutions. There is very weak evidence that povidone iodine mouthrinse is more effective than saline/placebo (RR 0.69, 95% CI 0.50 to 0.95, P = 0.02, I2 = 74%, three studies, 356 participants, high risk of bias), and that saline rinse is more effective than saline swab (RR 0.47, 95% CI 0.37 to 0.62, P < 0.001, I2 = 84%, four studies, 488 participants, high risk of bias) in reducing VAP. Due to variation in comparisons and outcomes among trials, there is insufficient evidence concerning the effects of other oral care solutions. AUTHORS' CONCLUSIONS: OHC including chlorhexidine mouthwash or gel reduces the risk of developing ventilator-associated pneumonia in critically ill patients from 25% to about 19%. However, there is no evidence of a difference in the outcomes of mortality, duration of mechanical ventilation or duration of ICU stay. There is no evidence that OHC including both antiseptics and toothbrushing is different from OHC with antiseptics alone, and some weak evidence to suggest that povidone iodine mouthrinse is more effective than saline/placebo, and saline rinse is more effective than saline swab in reducing VAP. There is insufficient evidence to determine whether powered toothbrushing or other oral care solutions are effective in reducing VAP. There is also insufficient evidence to determine whether any of the interventions evaluated in the studies are associated with adverse effects.

Interventions for the treatment of oral and oropharyngeal cancers: targeted therapy and immunotherapy.

BACKGROUND: Oral cancers are the sixth most common cancer worldwide, yet the prognosis following a diagnosis of oral cavity or oropharyngeal cancers remains poor, with approximately 50% survival at five years. Despite a sharp increase in research into molecularly targeted therapies and a rapid expansion in the number of clinical trials assessing new targeted therapies, their value for treating oral cancers is unclear. Therefore, it is important to summarise the evidence to determine the efficacy and toxicity of targeted therapies and immunotherapies for the treatment of these cancers. OBJECTIVES: To assess the effects of molecularly targeted therapies and immunotherapies, in addition to standard therapies, for the treatment of oral cavity or oropharyngeal cancers. SEARCH METHODS: We searched the following electronic databases: Cochrane Oral Health Group Trials Register (to 3 February 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2015, Issue 1), MEDLINE via Ovid (1946 to 3 February 2015) and EMBASE via Ovid (1980 to 3 February 2015). We searched the US National Institutes of Health Trials Register (clinicaltrials.gov), the World Health Organization Clinical Trials Registry Platform, the American Society of Clinical Oncology conference abstracts and the Radiation Therapy Oncology Group clinical trials protocols for ongoing trials. We placed no restrictions on the language or date of publication. SELECTION CRITERIA: We included randomised controlled trials where more than 50% of participants had primary tumours of the oral cavity or oropharynx, and which compared targeted therapy or immunotherapy, plus standard therapy, with standard therapy alone. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the results of the electronic searches, extracted data and assessed the risk of bias of the included studies. We attempted to contact study authors for missing data or clarification where necessary. We combined sufficiently similar studies in meta-analyses using random-effects models when there were at least four studies and fixed-effect models when fewer than four studies. We obtained or calculated a hazard ratio (HR) and 95% confidence interval (CI) for the primary outcomes where possible. For dichotomous outcomes, we reported risk ratios (RR) and 95% CIs. MAIN RESULTS: Twelve trials (2488 participants) satisfied the inclusion criteria. In the included trials, 12% of participants (298 participants) had tumours of the oral cavity and 59% (1468 participants) had oropharyngeal tumours. The remaining 29% had tumours of the larynx or hypopharynx and less than 1% had tumours at other sites.No included trial was at low risk of bias; seven had an unclear risk of bias, and five had a high risk of bias. We grouped trials by intervention type into three main comparisons: standard therapy plus epidermal growth factor receptor monoclonal antibody (EGFR mAb) therapy (follow-up period 24 to 70 months); standard therapy plus tyrosine kinase inhibitors (TKIs) (follow-up period 40 to 60 months) and standard therapy plus immunotherapy (follow-up period 24 to 70 months), all versus standard therapy alone.Moderate quality evidence showed that EGFR mAb therapy may result in 18% fewer deaths when added to standard therapy (HR of mortality 0.82; 95% CI 0.69 to 0.97; 1421 participants, three studies, 67% oropharyngeal tumours, 2% oral cavity tumours).There was also moderate quality evidence that EGFR mAb may result in 32% fewer locoregional failures when added to radiotherapy (RT) (HR 0.68; 95% CI 0.52 to 0.89; 424 participants, one study, 60% oropharyngeal tumours).A subgroup analysis separating studies by type of standard therapy (radiotherapy (RT) or chemoradiotherapy (CRT)) showed some evidence that adding EGFR mAb therapy to RT may result in a 30% reduction in the number of people whose disease progresses (HR 0.70; 95% CI 0.54 to 0.91; 424 participants, one study, 60% oropharyngeal tumours, unclear risk of bias). For the subgroup comparing EGFR mAb plus CRT with CRT alone there was insufficient evidence to determine whether adding EGFR mAb therapy to CRT impacts on progression-free survival (HR 1.08; 95% CI 0.89 to 1.32; 891 participants, one study, 70% oropharyngeal tumours, high risk of bias). The high subgroup heterogeneity meant that we were unable to pool these subgroups.There was evidence that adding cetuximab to standard therapy may result in increased skin toxicity and rash (RR 6.56; 95% CI 5.35 to 8.03; 1311 participants, two studies), but insufficient evidence to determine any difference in skin toxicity and rash in the case of nimotuzumab (RR 1.06; 95% CI 0.85 to 1.31; 92 participants, one study).There was insufficient evidence to determine whether TKIs added to standard therapy impacts on overall survival (HR 0.99; 95% CI 0.62 to 1.57; 271 participants, two studies; very low quality evidence), locoregional control (HR 0.89; 95% CI 0.53 to 1.49; 271 participants, two studies; very low quality evidence), disease-free survival (HR 1.51; 95% CI 0.61 to 3.71; 60 participants, one study; very low quality evidence) or progression-free survival (HR 0.80; 95% CI 0.51 to 1.28; 271 participants, two studies; very low quality evidence). We did find evidence of an increase in skin rash (erlotinib: RR 6.57; 95% CI 3.60 to 12.00; 191 participants, one study; lapatinib: RR 2.02; 95% CI 1.23 to 3.32; 67 participants, one study) and gastrointestinal complaints (lapatinib: RR 15.53; 95% CI 2.18 to 110.55; 67 participants, one study).We found very low quality evidence from one small trial that adding recombinant interleukin (rIL-2) to surgery may increase overall survival (HR 0.52; 95% CI 0.31 to 0.87; 201 participants, 62% oral cavity tumours, 38% oropharyngeal tumours) and there was insufficient evidence to determine whether rIL-2 impacts on adverse effects. AUTHORS' CONCLUSIONS: We found some evidence that adding EGFR mAb to standard therapy may increase overall survival, progression-free survival and locoregional control, while resulting in an increase in skin toxicity for some mAb (cetuximab).There is insufficient evidence to determine whether adding TKIs to standard therapies changes any of our primary outcomes.Very low quality evidence from a single study suggests that rIL-2 combined with surgery may increase overall survival compared with surgery alone.

Treatment of periodontal disease for glycaemic control in people with diabetes mellitus.

BACKGROUND: Glycaemic control is a key issue in the care of people with diabetes mellitus (DM). Periodontal disease is the inflammation and destruction of the underlying supporting tissues of the teeth. Some studies have suggested a bidirectional relationship between glycaemic control and periodontal disease. This review updates the previous version published in 2010. OBJECTIVES: The objective is to investigate the effect of periodontal therapy on glycaemic control in people with diabetes mellitus. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group Trials Register (to 31 December 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2014, Issue 11), MEDLINE via OVID (1946 to 31 December 2014), EMBASE via OVID (1980 to 31 December 2014), LILACS via BIREME (1982 to 31 December 2014), and CINAHL via EBSCO (1937 to 31 December 2014). ZETOC (1993 to 31 December 2014) and Web of Knowledge (1990 to 31 December 2014) were searched for conference proceedings. Additionally, two periodontology journals were handsearched for completeness, Annals of Periodontology (1996 to 2003) and Periodontology 2000 (1993 to 2003). We searched the US National Institutes of Health Trials Registry (http://clinicaltrials.gov) and the WHO Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: We searched for randomised controlled trials (RCTs) of people with type 1 or type 2 DM (T1DM/T2DM) with a diagnosis of periodontitis. Interventions included periodontal treatments such as mechanical debridement, surgical treatment and antimicrobial therapy. Two broad comparisons were proposed:1. periodontal therapy versus no active intervention/usual care;2. periodontal therapy versus alternative periodontal therapy. DATA COLLECTION AND ANALYSIS: For this review update, at least two review authors independently examined the titles and abstracts retrieved by the search, selected the included trials, extracted data from included trials and assessed included trials for risk of bias.Our primary outcome was blood glucose levels measured as glycated (glycosylated) haemoglobin assay (HbA1c).Our secondary outcomes included adverse effects, periodontal indices (bleeding on probing (BOP), clinical attachment level (CAL), gingival index (GI), plaque index (PI) and probing pocket depth (PPD)), cost implications and diabetic complications. MAIN RESULTS: We included 35 studies (including seven from the previous version of the review), which included 2565 participants in total. All studies used a parallel RCT design, and 33 studies (94%) only targeted T2DM patients. There was variation between studies with regards to included age groups (ages 18 to 80), duration of follow-up (3 to 12 months), use of antidiabetic therapy, and included participants' baseline HbA1c levels (from 5.5% to 13.1%).We assessed 29 studies (83%) as being at high risk of bias, two studies (6%) as being at low risk of bias, and four studies (11%) as unclear. Thirty-four of the studies provided data suitable for analysis under one or both of the two comparisons.Comparison 1: low quality evidence from 14 studies (1499 participants) comparing periodontal therapy with no active intervention/usual care demonstrated that mean HbA1c was 0.29% lower (95% confidence interval (CI) 0.48% to 0.10% lower) 3 to 4 months post-treatment, and 0.02% lower after 6 months (five studies, 826 participants; 95% CI 0.20% lower to 0.16% higher).Comparison 2: 21 studies (920 participants) compared different periodontal therapies with each other. There was only very low quality evidence for the multiple head-to-head comparisons, the majority of which were unsuitable to be pooled, and provided no clear evidence of a benefit for one periodontal intervention over another. We were able to pool the specific comparison between scaling and root planing (SRP) plus antimicrobial versus SRP and there was no consistent evidence that the addition of antimicrobials to SRP was of any benefit to delivering SRP alone (mean HbA1c 0.00% lower: 12 studies, 450 participants; 95% CI 0.22% lower to 0.22% higher) at 3-4 months post-treatment, or after 6 months (mean HbA1c 0.04% lower: five studies, 206 patients; 95% CI 0.41% lower to 0.32% higher).Less than half of the studies measured adverse effects. The evidence was insufficient to conclude whether any of the treatments were associated with harm. No other patient-reported outcomes (e.g. quality of life) were measured by the included studies, and neither were cost implications or diabetic complications.Studies showed varying degrees of success with regards to achieving periodontal health, with some showing high levels of residual inflammation following treatment. Statistically significant improvements were shown for all periodontal indices (BOP, CAL, GI, PI and PPD) at 3-4 and 6 months in comparison 1; however, this was less clear for individual comparisons within the broad category of comparison 2. AUTHORS' CONCLUSIONS: There is low quality evidence that the treatment of periodontal disease by SRP does improve glycaemic control in people with diabetes, with a mean percentage reduction in HbA1c of 0.29% at 3-4 months; however, there is insufficient evidence to demonstrate that this is maintained after 4 months.There was no evidence to support that one periodontal therapy was more effective than another in improving glycaemic control in people with diabetes mellitus.In clinical practice, ongoing professional periodontal treatment will be required to maintain clinical improvements beyond 6 months. Further research is required to determine whether adjunctive drug therapies should be used with periodontal treatment. Future RCTs should evaluate this, provide longer follow-up periods, and consider the inclusion of a third 'no treatment' control arm.Larger, well conducted and clearly reported studies are needed in order to understand the potential of periodontal treatment to improve glycaemic control among people with diabetes mellitus. In addition, it will be important in future studies that the intervention is effective in reducing periodontal inflammation and maintaining it at lowered levels throughout the period of observation.

Surgical techniques for the removal of mandibular wisdom teeth.

BACKGROUND: The surgical removal of mandibular wisdom teeth is one of the most common operations undertaken in oral and maxillofacial surgery. The most common indication for surgery is infection about a partially erupted tooth that is impacted against bone or soft tissues. Other indications include unrestorable caries, pulpal and periapical pathology, fracture of the tooth and cyst development, amongst others. Most commonly the benefits of surgical removal of a wisdom tooth include alleviation of the symptoms and signs of pericoronitis and its potential consequences. However, surgery is frequently associated with postoperative pain, swelling and trismus. Less commonly complications include infection, including dry socket, trigeminal nerve injuries and rarely fracture of the mandible. OBJECTIVES: To compare the relative benefits and risks of different techniques for undertaking various aspects or stages of the surgical extraction of mandibular wisdom teeth. SEARCH METHODS: We searched the Cochrane Oral Health Group's Trials Register (to 21 March 2014), CENTRAL (The Cochrane Library 2014, Issue 1), MEDLINE (OVID) (1946 to 21 March 2014) and EMBASE (OVID) (1980 to 21 March 2014). We searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform for ongoing trials. There were no restrictions regarding language or date of publication in the electronic searches. SELECTION CRITERIA: RCTs comparing surgical techniques for removal of mandibular wisdom teeth. DATA COLLECTION AND ANALYSIS: Two review authors conducted assessment of relevance, risk of bias and data extraction. Study authors were contacted for additional information. RRs were used for dichotomous data and MDs for continuous data, unless the event rate was very low and Peto ORs were used. The pairing of the split-mouth studies was taken into account in the analysis for both dichotomous and continuous outcomes, and parallel group and split-mouth studies were combined using the generic inverse variance method. Random-effects models were used provided there were more than three studies (fixed-effect models otherwise). MAIN RESULTS: A total of 35 trials (2569 patients) were included. The interventions under consideration fell into seven broad categories, with many comparisons including only a small number of trials. Twenty-one of the trials were assessed at high risk of bias, the remaining 14 as unclear. The results are described in the summary of findings tables.Triangular flaps were associated with a 71% reduction in alveolar osteitis at one week (RR 0.29, 95% CI 0.11 to 0.78; three trials, moderate quality) and reduction in pain at 24 hours (MD -0.21, 95% CI -0.32 to -0.10; two trials, moderate quality) compared with envelope flaps. There was no evidence of a difference in overall infection rates, in maximum mouth opening or in permanent sensation. However, there was some evidence that residual swelling after one week was slightly increased in the triangular flap groups compared to envelope flap types (MD 0.66 mm, 95% CI 0.26 to 1.07; two trials, low quality). We found no data on temporary sensation, or adverse events.There was low quality evidence from two studies, looking at the use of a retractor during third molar surgery, to indicate more cases of temporary altered sensation (up to one month) when a retractor was used (Peto OR 5.19, 95% CI 1.38 to 19.49; two trials, low quality). One study reported that this did not persist for more than six months in either group. We found no data for use of a retractor on other primary outcomes or adverse effects (including fracture of the mandible).Due to the small number of studies, the different comparisons evaluated, the variable outcomes reported and the paucity of useful data for all primary outcomes we were not able to draw any conclusions concerning bone removal in third molar surgery.There was insufficient evidence from single studies of very low quality on irrigation method (manual versus mechanical) or irrigation volume (low or high) to determine whether there were differences or not for the outcomes of alveolar osteitis or postoperative infection. We found no data for any of the other primary outcomes.There was insufficient evidence (low to very low quality) that any wound closure technique (primary versus secondary) was superior to another for the outcomes of alveolar osteitis, postoperative infection or maximum mouth opening achieved after seven days, or reactionary bleeding. There was evidence that secondary wound closure was associated with reduced pain at 24 hours (MD 0.79, 95% CI 0.35 to 1.24; four trials, moderate quality) and slightly reduced swelling after one week (MD 0.33, 95% CI 0.09 to 0.57; seven trials, moderate quality).We found no data on other primary outcomes.There was some evidence that the use of a surgical drain was associated with less postoperative swelling (MD -0.90, 95% CI -1.62 to -0.19; five trials, moderate quality) and greater maximum mouth opening one week after surgery (MD 3.72 mm, 95% CI 2.84 to 4.59; two trials, moderate quality). There was insufficient evidence from a single study (low quality) to determine whether the presence of a drain made any difference to pain at 24 hours postoperation. There were no data for the other primary outcomes.Although two RCTs compared coronectomy with complete extraction, flaws in the design and the unit of analysis of these studies meant that there were no reliable data available for inclusion. AUTHORS' CONCLUSIONS: The thirty-five included trials looked at a range of different surgical techniques. The comparisons related to seven broad aspects of the surgical procedures for impacted mandibular third molars: type of surgical flap raised, use of retractors, techniques for bone removal, wound irrigation, wound closure, wound drainage, and complete/incomplete tooth removal. The quality of the body of evidence for each of these comparisons was very low to moderate due to the small number of trials and patients, and the majority of the trials being at high risk of bias (65%) with the remainder at unclear risk of bias.The evidence for making changes to surgical practice is therefore limited. However, it is useful to describe the state of the research evidence supporting practice so that surgeons can make an informed choice in adopting new techniques, or continuing with established techniques.

Fluorides for the prevention of early tooth decay (demineralised white lesions) during fixed brace treatment.

BACKGROUND: Demineralised white lesions (DWLs) can appear on teeth during fixed brace treatment because of early decay around the brackets that attach the braces to the teeth. Fluoride is effective in reducing decay in susceptible individuals in the general population. Individuals receiving orthodontic treatment may be prescribed various forms of fluoride treatment. This review compares the effects of various forms of fluoride used during orthodontic treatment on the development of DWLs. This is an update of a Cochrane review first published in 2004. OBJECTIVES: The primary objective of this review was to evaluate the effects of fluoride in reducing the incidence of DWLs on the teeth during orthodontic treatment.The secondary objectives were to examine the effectiveness of different modes of fluoride delivery in reducing the incidence of DWLs, as well as the size of lesions. Participant-assessed outcomes, such as perception of DWLs, and oral health-related quality of life data were to be included, as would reports of adverse effects. SEARCH METHODS: We searched the Cochrane Oral Health Group's Trials Register (to 31 January 2013); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 12); MEDLINE via OVID (1946 to 31 January 2013); and EMBASE via OVID (1980 to 31 January 2013). SELECTION CRITERIA: We included trials if they met the following criteria: (1) parallel-group randomised clinical trials comparing the use of a fluoride-containing product versus placebo, no treatment or a different type of fluoride treatment, in which (2) the outcome of enamel demineralisation was assessed at the start and at the end of orthodontic treatment. DATA COLLECTION AND ANALYSIS: At least two review authors independently, in duplicate, conducted risk of bias assessments and extracted data. Authors of trials were contacted to obtain missing data or to ask for clarification of aspects of trial methodology. The Cochrane Collaboration's statistical guidelines were followed. MAIN RESULTS: For the 2013 update of this review, three changes were made to the protocol regarding inclusion criteria. Fourteen studies included in the previous version of the review were excluded from this update for the following reasons: five previously included studies were quasi-randomised, a further five were split-mouth studies, three measured outcomes on extracted teeth only and in one, the same fluoride intervention was used in each intervention group of the study.Three studies and 458 participants were included in this updated review. One study was assessed at low risk of bias for all domains, in one study the risk of bias was unclear and in the remaining study, the risk of bias was high.One placebo-controlled study of fluoride varnish applied every six weeks (253 participants, low risk of bias), provided moderate-quality evidence of an almost 70% reduction in DWLs (risk ratio (RR) 0.31, 95% confidence interval (CI) 0.21 to 0.44, P value < 0.001). This finding is considered to provide moderate-quality evidence for this intervention because it has not yet been replicated by further studies in orthodontic participants.One study compared two different formulations of fluoride toothpaste and mouthrinse prescribed for participants undergoing orthodontic treatment (97 participants, unclear risk of bias) and found no difference between an amine fluoride and stannous fluoride toothpaste/mouthrinse combination and a sodium fluoride toothpaste/mouthrinse combination for the outcomes of white spot index, visible plaque index and gingival bleeding index.One small study (37 participants) compared the use of an intraoral fluoride-releasing glass bead device attached to the brace versus a daily fluoride mouthrinse. The study was assessed at high risk of bias because a substantial number of participants were lost to follow-up, and compliance with use of the mouthrinse was not measured.Neither secondary outcomes of this review nor adverse effects of interventions were reported in any of the included studies. AUTHORS' CONCLUSIONS: This review found some moderate evidence that fluoride varnish applied every six weeks at the time of orthodontic review during treatment is effective, but this finding is based on a single study. Further adequately powered, double-blind, randomised controlled trials are required to determine the best means of preventing DWLs in patients undergoing orthodontic treatment and the most accurate means of assessing compliance with treatment and possible adverse effects. Future studies should follow up participants beyond the end of orthodontic treatment to determine the effect of DWLs on participant satisfaction with treatment.

Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children.

BACKGROUND: Prominent lower front teeth (termed reverse bite; under bite; Class III malocclusion) may be due to a combination of the jaw or tooth positions or both. The upper jaw (maxilla) can be too far back or the lower jaw (mandible) too far forward, or both. Prominent lower front teeth can also occur if the upper front teeth (incisors) are tipped back or the lower front teeth are tipped forwards, or both. Various treatment approaches have been described to correct prominent lower front teeth in children and adolescents. OBJECTIVES: To assess the effects of orthodontic treatment for prominent lower front teeth in children and adolescents. SEARCH METHODS: We searched the following databases: Cochrane Oral Health Group's Trials Register (to 7 January 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 12), MEDLINE via OVID (1946 to 7 January 2013), and EMBASE via OVID (1980 to 7 January 2013). SELECTION CRITERIA: Randomised controlled trials (RCTs) recruiting children or adolescents or both (aged 16 years or less) receiving any type of orthodontic treatment to correct prominent lower front teeth (Class III malocclusion). Orthodontic treatments were compared with control groups who received either no treatment, delayed treatment or a different active intervention. DATA COLLECTION AND ANALYSIS: Screening of references, identification of included and excluded studies, data extraction and assessment of the risk of bias of the included studies was performed independently and in duplicate by two review authors. The mean differences with 95% confidence intervals were calculated for continuous data. Meta-analysis was only undertaken when studies of similar comparisons reported comparable outcome measures. A fixed-effect model was used. The I2 statistic was used as a measure of statistical heterogeneity. MAIN RESULTS: Seven RCTs with a total of 339 participants were included in this review. One study was assessed as at low risk of bias, three studies were at high risk of bias, and in the remaining three studies risk of bias was unclear. Four studies reported on the use of a facemask, two on the chin cup, one on the tandem traction bow appliance, and one on mandibular headgear. One study reported on both the chin cup and mandibular headgear appliances.One study (n = 73, low quality evidence), comparing a facemask to no treatment, reported a mean difference (MD) in overjet of 4.10 mm (95% confidence interval (CI) 3.04 to 5.16; P value < 0.0001) favouring the facemask treatment. Two studies comparing facemasks to untreated control did not report the outcome of overjet. Three studies (n = 155, low quality evidence) reported ANB (an angular measurement relating the positions of the top and bottom jaws) differences immediately after treatment with a facemask when compared to an untreated control. The pooled data showed a statistically significant MD in ANB in favour of the facemask of 3.93 ° (95% CI 3.46 to 4.39; P value < 0.0001). There was significant heterogeneity between these studies (I2 = 82%). This is likely to have been caused by the different populations studied and the different ages at the time of treatment.One study (n = 73, low quality evidence) reported outcomes of the use of the facemask compared to an untreated control at three years follow-up. This study showed that improvements in overjet and ANB were still present three years post-treatment. In this study, adverse effects were reported but due to the low prevalence of temporomandibular (TMJ) signs and symptoms no analysis was undertaken.Two studies (n = 90, low quality evidence) compared the chin cup with an untreated control. Both studies found a statistically significant improvement in ANB, and one study also found an improvement in the Wits appraisal. Data from these two studies were not suitable for pooling.A single study of the tandem traction bow appliance compared to untreated control (n = 30, very low quality evidence) showed a statistically significant difference in both overjet and ANB favouring the intervention group.The remaining two studies did not report the primary outcome of this review. AUTHORS' CONCLUSIONS: There is some evidence that the use of a facemask to correct prominent lower front teeth in children is effective when compared to no treatment on a short-term basis. However, in view of the general poor quality of the included studies, these results should be viewed with caution. Further randomised controlled trials with long follow-up are required.

Interventions for the management of dry mouth: non-pharmacological interventions.

BACKGROUND: Xerostomia is the subjective sensation of dry mouth. Common causes of xerostomia include adverse effects of many commonly prescribed medications, disease (e.g. Sjogren's Syndrome) and radiotherapy treatment for head and neck cancers. Non-pharmacological techniques such as acupuncture or mild electrostimulation may be used to improve symptoms. OBJECTIVES: To assess the effects of non-pharmacological interventions administered to stimulate saliva production for the relief of dry mouth. SEARCH METHODS: We searched the Cochrane Oral Health Group's Trials Register (to 16th April 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 3), MEDLINE via OVID (1948 to 16th April 2013), EMBASE via OVID (1980 to 16th April 2013), AMED via OVID (1985 to 16th April 2013), CINAHL via EBSCO (1981 to 16th April 2013), and CANCERLIT via PubMed (1950 to 16th April 2013). The metaRegister of Controlled Clinical Trials (www.controlled-trials.com) and ClinicalTrials.gov (www.clinicaltrials.gov) were also searched to identify ongoing and completed trials. References lists of included studies and relevant reviews were also searched. There were no restrictions on the language of publication or publication status. SELECTION CRITERIA: We included parallel group randomised controlled trials of non-pharmacological interventions to treat dry mouth, where participants had dry mouth symptoms at baseline. DATA COLLECTION AND ANALYSIS: At least two review authors assessed each of the included studies to confirm eligibility, assess risk of bias and extract data using a piloted data extraction form. We calculated mean difference (MD) and 95% confidence intervals (CI) for continuous outcomes or where different scales were used to assess an outcome, we calculated standardised mean differences (SMD) together with 95% CIs. We attempted to extract data on adverse effects of interventions. Where data were missing or unclear we attempted to contact study authors to obtain further information. MAIN RESULTS: There were nine studies (total 366 participants randomised) included in this review of non-pharmacological interventions for dry mouth which were divided into three comparisons. Eight studies were assessed at high risk of bias in at least one domain and the remaining study was at unclear risk of bias.Five small studies (total 153 participants, with dry mouth following radiotherapy treatment) compared acupuncture with placebo. Four were assessed at high risk and one at unclear risk of bias. Two trials reported outcome data for dry mouth in a form suitable for meta-analysis. The pooled estimate of these two trials (70 participants, low quality evidence) showed no difference between acupuncture and control in dry mouth symptoms (SMD -0.34, 95% CI -0.81 to 0.14, P value 0.17, I(2) = 39%) with the confidence intervals including both a possible reduction or a possible increase in dry mouth symptoms. Acupuncture was associated with more adverse effects (tiny bruises and tiredness which were mild and temporary). There was a very small increase in unstimulated whole saliva (UWS) at the end of 4 to 6 weeks of treatment (three trials, 71 participants, low quality evidence) (MD 0.02 ml/minute, 95% CI 0 to 0.04, P value 0.04, I(2) = 57%), and this benefit persisted at the 12-month follow-up evaluation (two trials, 54 participants, low quality evidence) (UWS, MD 0.06 ml/minute, 95% CI 0.01 to 0.11, P value 0.03, I(2) = 10%). For the outcome of stimulated whole saliva (SWS, three trials, 71 participants, low quality evidence) there was a benefit favouring acupuncture (MD 0.19 ml/minute, 95% CI 0.07 to 0.31, P value 0.002, I(2) = 1%) an effect which also persisted at the 12-month follow-up evaluation (SWS MD 0.28 ml/minute, 95% CI 0.09 to 0.47, P value 0.004, I(2) = 0%) (two trials, 54 participants, low quality evidence).Two small studies, both at high risk of bias, compared the use of an electrostimulation device with a placebo device in participants with Sjögren's Syndrome (total 101 participants). A further study, also at high risk of bias, compared acupuncture-like electrostimulation of different sets of points in participants who had previously been treated with radiotherapy. None of these studies reported the outcome of dry mouth. There was no difference between electrostimulation and placebo in the outcomes of UWS or SWS at the end of the 4-week treatment period in the one study (very low that provided data for these outcomes. No adverse effects were reported.A single study at high risk of bias, compared the stimulatory effect of powered versus manual toothbrushing and found no difference for the outcomes of UWS or SWS. AUTHORS' CONCLUSIONS: There is low quality evidence that acupuncture is no different from placebo acupuncture with regard to dry mouth symptoms, which is the most important outcome. This may be because there were insufficient participants included in the two trials to show a possible effect or it may be that there was some benefit due to 'placebo' acupuncture which could have biased the effect to the null. There is insufficient evidence to determine the effects of electrostimulation devices on dry mouth symptoms. It is well known that dry mouth symptoms may be problematic even when saliva production is increased, yet only two of the trials that evaluated acupuncture reported dry mouth symptoms, a worrying reporting bias. There is some low quality evidence that acupuncture results in a small increase in saliva production in patients with dry mouth following radiotherapy.There is insufficient evidence to determine the effects of electrostimulation devices on dry mouth symptoms or saliva production in patients with Sjögren's Syndrome. Reported adverse effects of acupuncture are mild and of short duration, and there were no reported adverse effects from electrostimulation.

Interventions for the management of dry mouth: non-pharmacological interventions.

BACKGROUND: Xerostomia is the subjective sensation of dry mouth. Common causes of xerostomia include adverse effects of many commonly prescribed medications, disease (e.g. Sjogren's Syndrome) and radiotherapy treatment for head and neck cancers. Non-pharmacological techniques such as acupuncture or mild electrostimulation may be used to improve symptoms. OBJECTIVES: To assess the effects of non-pharmacological interventions administered to stimulate saliva production for the relief of dry mouth. SEARCH METHODS: We searched the Cochrane Oral Health Group's Trials Register (to 16th April 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 3), MEDLINE via OVID (1948 to 16th April 2013), EMBASE via OVID (1980 to 16th April 2013), AMED via OVID (1985 to 16th April 2013), CINAHL via EBSCO (1981 to 16th April 2013), and CANCERLIT via PubMed (1950 to 16th April 2013). The metaRegister of Controlled Clinical Trials (www.controlled-trials.com) and ClinicalTrials.gov (www.clinicaltrials.gov) were also searched to identify ongoing and completed trials. References lists of included studies and relevant reviews were also searched. There were no restrictions on the language of publication or publication status. SELECTION CRITERIA: We included parallel group randomised controlled trials of non-pharmacological interventions to treat dry mouth, where participants had dry mouth symptoms at baseline. DATA COLLECTION AND ANALYSIS: At least two review authors assessed each of the included studies to confirm eligibility, assess risk of bias and extract data using a piloted data extraction form. We calculated mean difference (MD) and 95% confidence intervals (CI) for continuous outcomes or where different scales were used to assess an outcome, we calculated standardised mean differences (SMD) together with 95% CIs. We attempted to extract data on adverse effects of interventions. Where data were missing or unclear we attempted to contact study authors to obtain further information. MAIN RESULTS: There were nine studies (total 366 participants randomised) included in this review of non-pharmacological interventions for dry mouth which were divided into three comparisons. Eight studies were assessed at high risk of bias in at least one domain and the remaining study was at unclear risk of bias.Five small studies (total 153 participants, with dry mouth following radiotherapy treatment) compared acupuncture with placebo. Four were assessed at high risk and one at unclear risk of bias. Two trials reported outcome data for dry mouth in a form suitable for meta-analysis. The pooled estimate of these two trials (70 participants, low quality evidence) showed no difference between acupuncture and control in dry mouth symptoms (SMD -0.34, 95% CI -0.81 to 0.14, P value 0.17, I(2) = 39%) with the confidence intervals including both a possible reduction or a possible increase in dry mouth symptoms. Acupuncture was associated with more adverse effects (tiny bruises and tiredness which were mild and temporary). There was a very small increase in unstimulated whole saliva (UWS) at the end of 4 to 6 weeks of treatment (three trials, 71 participants, low quality evidence) (MD 0.02 ml/minute, 95% CI 0 to 0.04, P value 0.04, I(2) = 57%), and this benefit persisted at the 12-month follow-up evaluation (two trials, 54 participants, low quality evidence) (UWS, MD 0.06 ml/minute, 95% CI 0.01 to 0.11, P value 0.03, I(2) = 10%). For the outcome of stimulated whole saliva (SWS, three trials, 71 participants, low quality evidence) there was a benefit favouring acupuncture (MD 0.19 ml/minute, 95% CI 0.07 to 0.31, P value 0.002, I(2) = 1%) an effect which also persisted at the 12-month follow-up evaluation (SWS MD 0.28 ml/minute, 95% CI 0.09 to 0.47, P value 0.004, I(2) = 0%) (two trials, 54 participants, low quality evidence).Two small studies, both at high risk of bias, compared the use of an electrostimulation device with a placebo device in participants with Sjögren's Syndrome (total 101 participants). A further study, also at high risk of bias, compared acupuncture-like electrostimulation of different sets of points in participants who had previously been treated with radiotherapy. None of these studies reported the outcome of dry mouth. There was no difference between electrostimulation and placebo in the outcomes of UWS or SWS at the end of the 4-week treatment period in the one study (very low that provided data for these outcomes. No adverse effects were reported.A single study at high risk of bias, compared the stimulatory effect of powered versus manual toothbrushing and found no difference for the outcomes of UWS or SWS. AUTHORS' CONCLUSIONS: There is low quality evidence that acupuncture is no different from placebo acupuncture with regard to dry mouth symptoms, which is the most important outcome. This may be because there were insufficient participants included in the two trials to show a possible effect or it may be that there was some benefit due to 'placebo' acupuncture which could have biased the effect to the null. There is insufficient evidence to determine the effects of electrostimulation devices on dry mouth symptoms. It is well known that dry mouth symptoms may be problematic even when saliva production is increased, yet only two of the trials that evaluated acupuncture reported dry mouth symptoms, a worrying reporting bias. There is some low quality evidence that acupuncture results in a small increase in saliva production in patients with dry mouth following radiotherapy.There is insufficient evidence to determine the effects of electrostimulation devices on dry mouth symptoms or saliva production in patients with Sjögren's Syndrome. Reported adverse effects of acupuncture are mild and of short duration, and there were no reported adverse effects from electrostimulation.

Oral hygiene care for critically ill patients to prevent ventilator-associated pneumonia.

BACKGROUND: Ventilator-associated pneumonia (VAP) is defined as pneumonia developing in persons who have received mechanical ventilation for at least 48 hours. VAP is a potentially serious complication in these patients who are already critically ill. Oral hygiene care (OHC), using either a mouthrinse, gel, toothbrush, or combination, together with aspiration of secretions may reduce the risk of VAP in these patients. OBJECTIVES: To assess the effects of OHC on the incidence of VAP in critically ill patients receiving mechanical ventilation in intensive care units (ICUs) in hospitals. SEARCH METHODS: We searched the Cochrane Oral Health Group's Trials Register (to 14 January 2013), CENTRAL (The Cochrane Library 2012, Issue 12), MEDLINE (OVID) (1946 to 14 January 2013), EMBASE (OVID) (1980 to 14 January 2013), LILACS (BIREME) (1982 to 14 January 2013), CINAHL (EBSCO) (1980 to 14 January 2013), Chinese Biomedical Literature Database (1978 to 14 January 2013), China National Knowledge Infrastructure (1994 to 14 January 2013), Wan Fang Database (January 1984 to 14 January 2013), OpenGrey and ClinicalTrials.gov (to 14 January 2013). There were no restrictions regarding language or date of publication. SELECTION CRITERIA: We included randomised controlled trials (RCTs) evaluating the effects of OHC (mouthrinse, swab, toothbrush or combination) in critically ill patients receiving mechanical ventilation. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed all search results, extracted data and undertook risk of bias. We contacted study authors for additional information. Trials with similar interventions and outcomes were pooled reporting odds ratios (OR) for dichotomous outcomes and mean differences (MD) for continuous outcomes using random-effects models unless there were fewer than four studies. MAIN RESULTS: Thirty-five RCTs (5374 participants) were included. Five trials (14%) were assessed at low risk of bias, 17 studies (49%) were at high risk of bias, and 13 studies (37%) were assessed at unclear risk of bias in at least one domain. There were four main comparisons: chlorhexidine (CHX mouthrinse or gel) versus placebo/usual care, toothbrushing versus no toothbrushing, powered versus manual toothbrushing and comparisons of oral care solutions.There is moderate quality evidence from 17 RCTs (2402 participants, two at high, 11 at unclear and four at low risk of bias) that CHX mouthrinse or gel, as part of OHC, compared to placebo or usual care is associated with a reduction in VAP (OR 0.60, 95% confidence intervals (CI) 0.47 to 0.77, P < 0.001, I(2) = 21%). This is equivalent to a number needed to treat (NNT) of 15 (95% CI 10 to 34) indicating that for every 15 ventilated patients in intensive care receiving OHC including chlorhexidine, one outcome of VAP will be prevented. There is no evidence of a difference between CHX and placebo/usual care in the outcomes of mortality (OR 1.10, 95% CI 0.87 to 1.38, P = 0.44, I(2) = 2%, 15 RCTs, moderate quality evidence), duration of mechanical ventilation (MD 0.09, 95% CI -0.84 to 1.01 days, P = 0.85, I(2) = 24%, six RCTs, moderate quality evidence), or duration of ICU stay (MD -0.21, 95% CI -1.48 to 1.89 days, P = 0.81, I(2) = 9%, six RCTs, moderate quality evidence). There was insufficient evidence to determine whether there is a difference between CHX and placebo/usual care in the outcomes of duration of use of systemic antibiotics, oral health indices, microbiological cultures, caregivers preferences or cost. Only three studies reported any adverse effects, and these were mild with similar frequency in CHX and control groups.From three trials of children aged from 0 to 15 years (342 participants, moderate quality evidence) there is no evidence of a difference between OHC with CHX and placebo for the outcomes of VAP (OR 1.07, 95% CI 0.65 to 1.77, P = 0.79, I(2) = 0%), or mortality (OR 0.73, 95% CI 0.41 to 1.30, P = 0.28, I(2) = 0%), and insufficient evidence to determine the effect on the outcomes of duration of ventilation, duration of ICU stay, use of systemic antibiotics, plaque index, microbiological cultures or adverse effects, in children.Based on four RCTs (828 participants, low quality evidence) there is no evidence of a difference between OHC including toothbrushing (± CHX) compared to OHC without toothbrushing (± CHX) for the outcome of VAP (OR 0.69, 95% CI 0.36 to 1.29, P = 0.24 , I(2) = 64%) and no evidence of a difference for mortality (OR 0.85, 95% CI 0.62 to 1.16, P = 0.31, I(2) = 0%, four RCTs, moderate quality evidence). There is insufficient evidence to determine whether there is a difference due to toothbrushing for the outcomes of duration of mechanical ventilation, duration of ICU stay, use of systemic antibiotics, oral health indices, microbiological cultures, adverse effects, caregivers preferences or cost.Only one trial compared use of a powered toothbrush with a manual toothbrush providing insufficient evidence to determine the effect on any of the outcomes of this review.A range of other oral care solutions were compared. There is some weak evidence that povidone iodine mouthrinse is more effective than saline in reducing VAP (OR 0.35, 95% CI 0.19 to 0.65, P = 0.0009, I(2) = 53%) (two studies, 206 participants, high risk of bias). Due to the variation in comparisons and outcomes among the trials in this group there is insufficient evidence concerning the effects of other oral care solutions on the outcomes of this review. AUTHORS' CONCLUSIONS: Effective OHC is important for ventilated patients in intensive care. OHC that includes either chlorhexidine mouthwash or gel is associated with a 40% reduction in the odds of developing ventilator-associated pneumonia in critically ill adults. However, there is no evidence of a difference in the outcomes of mortality, duration of mechanical ventilation or duration of ICU stay. There is no evidence that OHC including both CHX and toothbrushing is different from OHC with CHX alone, and some weak evidence to suggest that povidone iodine mouthrinse is more effective than saline in reducing VAP. There is insufficient evidence to determine whether powered toothbrushing or other oral care solutions are effective in reducing VAP.

Initial arch wires for tooth alignment during orthodontic treatment with fixed appliances.

BACKGROUND: Initial arch wires are the first arch wires to be inserted into the fixed appliance at the beginning of orthodontic treatment and are used mainly for the alignment of teeth by correcting crowding and rotations. With a number of different types of orthodontic arch wires available for initial tooth alignment, it is important to understand which wire is most efficient, as well as which wires cause the least amount of root resorption and pain during the initial aligning stage of treatment. This is an update of the review 'Initial arch wires for alignment of crooked teeth with fixed orthodontic braces' first published in the Cochrane Database of Systematic Reviews 2010, Issue 4. OBJECTIVES: To assess the effects of initial arch wires for alignment of teeth with fixed orthodontic braces in relation to alignment speed, root resorption and pain intensity. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 2 August 2012), CENTRAL (The Cochrane Library 2012, Issue 7), MEDLINE via OVID (1950 to 2 August 2012) and EMBASE via OVID (1980 to 2 August 2012). We also searched the reference lists of relevant articles. There was no restriction with regard to publication status or language of publication. We contacted all authors of included studies to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of initial arch wires to align teeth with fixed orthodontic braces. Only studies involving participants with upper and/or lower full arch fixed orthodontic appliances were included. DATA COLLECTION AND ANALYSIS: Two review authors were responsible for study selection, validity assessment and data extraction. All disagreements were resolved by discussion amongst the review team. Corresponding authors of included studies were contacted to obtain missing information. MAIN RESULTS: Nine RCTs with 571 participants were included in this review. All trials were at high risk of bias and a number of methodological limitations were identified. All trials had at least one potentially confounding factor (such as bracket type, slot size, ligation method, extraction of teeth) which is likely to have influenced the outcome and was not controlled in the trial. None of the trials reported the important adverse outcome of root resorption.Three groups of comparisons were made.(1) Multistrand stainless steel initial arch wires compared to superelastic nickel titanium (NiTi) initial arch wires. There were four trials in this group, with different comparisons and outcomes reported at different times. No meta-analysis was possible. There is insufficient evidence from these trials to determine whether or not there is a difference in either rate of alignment or pain between stainless steel and NiTi initial arch wires.(2) Conventional (stabilised) NiTi initial arch wires compared to superelastic NiTi initial arch wires. There were two trials in this group, one reporting the outcome of alignment over 6 months and the other reporting pain over 1 week. There is insufficient evidence from these trials to determine whether or not there is any difference between conventional (stabilised) and superelastic NiTi initial arch wires with regard to either alignment or pain.(3) Single-strand superelastic NiTi initial arch wires compared to other NiTi (coaxial, copper NiTi (CuNiTi) or thermoelastic) initial arch wires. The three trials in this comparison each compared a different product against single-strand superelastic NiTi. There is very weak unreliable evidence, based on one very small study (n = 24) at high risk of bias, that coaxial superelastic NiTi may produce greater tooth movement over 12 weeks, but no information on associated pain or root resorption. This result should be interpreted with caution until further research evidence is available. There is insufficient evidence to determine whether or not there is a difference between either thermoelastic or CuNiTi and superelastic NiTi initial arch wires. AUTHORS' CONCLUSIONS: There is no reliable evidence from the trials included in this review that any specific initial arch wire material is better or worse than another with regard to speed of alignment or pain. There is no evidence at all about the effect of initial arch wire materials on the important adverse effect of root resorption. Further well-designed and conducted, adequately-powered, RCTs are required to determine whether the performance of initial arch wire materials as demonstrated in the laboratory, makes a clinically important difference to the alignment of teeth in the initial stage of orthodontic treatment in patients.

Extraction of primary (baby) teeth for unerupted palatally displaced permanent canine teeth in children.

BACKGROUND: The permanent canine tooth in the maxillary (upper) jaw sometimes does not erupt into the mouth correctly. In about 1% to 3% of the population these teeth will be diverted into the roof of the mouth (palatally). It has been suggested that if the primary canine is removed at the right time this palatal eruption might be avoided. This is an update of a Cochrane review first published in 2009. OBJECTIVES: To evaluate the effect of extracting the primary maxillary canine on the eruption of the palatally ectopic maxillary permanent canine. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 20 April 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 1), MEDLINE via OVID (1946 to 20 April 2012) and EMBASE via OVID (1980 to 20 April 2012). There were no restrictions regarding language or date of publication. SELECTION CRITERIA: Trials were selected if they met the following criteria: a randomised or quasi-randomised controlled trial, involving the extraction of the deciduous maxillary canine and assessing eruption/non-eruption of the palatally displaced maxillary permanent canine. DATA COLLECTION AND ANALYSIS: Data extraction was undertaken independently by two review authors. The primary outcome was the reported prevalence of eruption or non-eruption of the ectopic permanent canine into the mouth following observation or intervention. Results were to be expressed as risk ratios for dichotomous outcomes with 95% confidence intervals and mean differences for continuous outcomes. Heterogeneity was to be investigated, including both clinical and methodological factors. Authors of trials were contacted to request unpublished data. MAIN RESULTS: Reports of two randomised controlled trials previously excluded from an earlier version of the review due to "deficiencies in reporting, insufficient data" have now been included. These two trials included approximately 128 children, with more than 150 palatally displaced canine teeth, and both were conducted by the same research group. Data presented in the trial reports are either incomplete or inconsistent. Both trials are at high risk of bias. It must be emphasised that both trials have serious deficiencies in the way they were designed, conducted, and reported, and attempts to contact the authors to obtain detailed information and clarify inconsistencies have been unsuccessful. Allocation to treatment appears to be at the level of the individual, but outcomes of successful treatment relate to included teeth and data are not reported for each treatment group. Adverse effects are not reported. Neither trial provides any evidence to guide clinical decision making. AUTHORS' CONCLUSIONS: There is currently no evidence of the effects of extraction of primary canine teeth in 10-13 year old children with one or two palatally displaced permanent canine teeth.

Antibiotics to prevent complications following tooth extractions.

BACKGROUND: The most frequent indications for tooth extractions are dental caries and periodontal infections, and these extractions are generally done by general dental practitioners. Antibiotics may be prescribed to patients undergoing extractions to prevent complications due to infection. OBJECTIVES: To determine the effect of antibiotic prophylaxis on the development of infectious complications following tooth extractions. SEARCH METHODS: The following electronic databases were searched: the Cochrane Oral Health Group's Trials Register (to 25 January 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 1), MEDLINE via OVID (1948 to 25 January 2012), EMBASE via OVID (1980 to 25 January 2012) and LILACS via BIREME (1982 to 25 January 2012). There were no restrictions regarding language or date of publication. SELECTION CRITERIA: We included randomised double-blind placebo-controlled trials of antibiotic prophylaxis in patients undergoing tooth extraction(s) for any indication. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias for the included studies and extracted data. We contacted trial authors for further details where these were unclear. For dichotomous outcomes we calculated risk ratios (RR) and 95% confidence intervals (CI) using random-effects models. For continuous outcomes we used mean differences (MD) with 95% CI using random-effects models. We examined potential sources of heterogeneity. The quality of the body of evidence has been assessed using the GRADE tool. MAIN RESULTS: This review included 18 double-blind placebo-controlled trials with a total of 2456 participants. Five trials were assessed at unclear risk of bias, thirteen at high risk, and none at low risk of bias. Compared to placebo, antibiotics probably reduce the risk of infection in patients undergoing third molar extraction(s) by approximately 70% (RR 0.29 (95% CI 0.16 to 0.50) P < 0.0001, 1523 participants, moderate quality evidence) which means that 12 people (range 10-17) need to be treated with antibiotics to prevent one infection following extraction of impacted wisdom teeth. There is evidence that antibiotics may reduce the risk of dry socket by 38% (RR 0.62 (95% CI 0.41 to 0.95) P = 0.03, 1429 participants, moderate quality evidence) which means that 38 people (range 24-250) need to take antibiotics to prevent one case of dry socket following extraction of impacted wisdom teeth. There is also some evidence that patients who have prophylactic antibiotics may have less pain (MD -8.17 (95% CI -11.90 to -4.45) P < 0.0001, 372 participants, moderate quality evidence ) overall 7 days after the extraction compared to those receiving placebo, which may be a direct result of the lower risk of infection. There is no evidence of a difference between antibiotics and placebo in the outcomes of fever (RR 0.34, 95% CI 0.06 to 1.99), swelling (RR 0.92, 95% CI 0.65 to 1.30) or trismus (RR 0.84, 95% CI 0.42 to 1.71) 7 days after tooth extraction.Antibiotics are associated with an increase in generally mild and transient adverse effects compared to placebo (RR 1.98 (95% CI 1.10 to 3.59) P = 0.02) which means that for every 21 people (range 8-200) who receive antibiotics, an adverse effect is likely. AUTHORS' CONCLUSIONS: Although general dentists perform dental extractions because of severe dental caries or periodontal infection, there were no trials identified which evaluated the role of antibiotic prophylaxis in this group of patients in this setting. All of the trials included in this review included healthy patients undergoing extraction of impacted third molars, often performed by oral surgeons. There is evidence that prophylactic antibiotics reduce the risk of infection, dry socket and pain following third molar extraction and result in an increase in mild and transient adverse effects. It is unclear whether the evidence in this review is generalisable to those with concomitant illnesses or immunodeficiency, or those undergoing the extraction of teeth due to severe caries or periodontitis. However, patients at a higher risk of infection are more likely to benefit from prophylactic antibiotics, because infections in this group are likely to be more frequent, associated with complications and be more difficult to treat. Due to the increasing prevalence of bacteria which are resistant to treatment by currently available antibiotics, clinicians should consider carefully whether treating 12 healthy patients with antibiotics to prevent one infection is likely to do more harm than good.

Hormone therapy in postmenopausal women and risk of endometrial hyperplasia.

BACKGROUND: Reduced circulating estrogen levels around the time of the menopause can induce unacceptable symptoms that affect the health and well-being of women. Hormone therapy (both unopposed estrogen and estrogen/progestogen combinations) is an effective treatment for these symptoms, but is associated with risk of harms. Guidelines recommend that hormone therapy be given at the lowest effective dose and treatment should be reviewed regularly. The aim of this review is to identify the minimum dose(s) of progestogen required to be added to estrogen so that the rate of endometrial hyperplasia is not increased compared to placebo. OBJECTIVES: The objective of this review is to assess which hormone therapy regimens provide effective protection against the development of endometrial hyperplasia or carcinoma. SEARCH METHODS: We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched January 2012), The Cochrane Library (Issue 1, 2012), MEDLINE (1966 to January 2012), EMBASE (1980 to January 2012), Current Contents (1993 to May 2008), Biological Abstracts (1969 to 2008), Social Sciences Index (1980 to May 2008), PsycINFO (1972 to January 2012) and CINAHL (1982 to May 2008). Attempts were made to identify trials from citation lists of reviews and studies retrieved, and drug companies were contacted for unpublished data. SELECTION CRITERIA: Randomised comparisons of unopposed estrogen therapy, combined continuous estrogen-progestogen therapy, sequential estrogen-progestogen therapy with each other or placebo, administered over a minimum period of 12 months. Incidence of endometrial hyperplasia/carcinoma assessed by a biopsy at the end of treatment was a required outcome. Data on adherence to therapy, rates of additional interventions, and withdrawals owing to adverse events were also extracted. DATA COLLECTION AND ANALYSIS: In this update, 46 studies were included. Odds ratios (ORs) were calculated for dichotomous outcomes. The small numbers of studies in each comparison and the clinical heterogeneity precluded meta-analysis for many outcomes. MAIN RESULTS: Unopposed estrogen is associated with increased risk of endometrial hyperplasia at all doses, and durations of therapy between one and three years. For women with a uterus the risk of endometrial hyperplasia with hormone therapy comprising low-dose estrogen continuously combined with a minimum of 1 mg norethisterone acetate (NETA) or 1.5 mg medroxyprogesterone acetate (MPA) is not significantly different from placebo at two years (1 mg NETA: OR 0.04; 95% confidence interval (CI) 0 to 2.8; 1.5 mg MPA: no hyperplasia events). AUTHORS' CONCLUSIONS: Hormone therapy for postmenopausal women with an intact uterus should comprise both estrogen and progestogen to reduce the risk of endometrial hyperplasia.

Sedation of children undergoing dental treatment.

BACKGROUND: Children's fear about dental treatment may lead to behaviour management problems for the dentist, which can be a barrier to the successful dental treatment of children. Sedation can be used to relieve anxiety and manage behaviour in children undergoing dental treatment. There is a need to determine from published research which agents, dosages and regimens are effective. OBJECTIVES: To evaluate the efficacy and relative efficacy of conscious sedation agents and dosages for behaviour management in paediatric dentistry. SEARCH METHODS: Electronic searches of MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Dissertation Abstracts, SIGLE, the World Wide Web (Google) and the Community of Science Database were conducted for relevant trials and references up to 4th August 2011. Reference lists from relevant articles were scanned and the authors contacted to identify trials and obtain additional information. There were no language restrictions. Trials pre-1966 were not searched. SELECTION CRITERIA: Studies were selected if they met the following criteria: randomised controlled trials of conscious sedation comparing two or more drugs/techniques/placebo undertaken by the dentist or one of the dental team in children up to 16 years of age. Crossover trials were excluded. DATA COLLECTION AND ANALYSIS: Information regarding methods, participants, interventions, outcome measures and results were independently extracted, in duplicate, by two review authors. Where information in trial reports was unclear or incomplete authors of trials were contacted. Trials were assessed for risk of bias. The Cochrane Collaboration statistical guidelines were followed. MAIN RESULTS: Thirty-six studies were included with a total of 2810 participants. Thirty trials (83%) were at high risk of bias and six (17%) were at unclear risk of bias. There were 28 different sedatives used with or without inhalational nitrous oxide. Dosages, mode of administration and time of administration varied widely. Trials were grouped into placebo-controlled, dosage and head-to-head comparisons. Meta-analysis of the available data was possible for studies investigating oral midazolam vs placebo only. There is weak evidence from five small clinically heterogeneous trials at high risk of bias, that the use of oral midazolam in doses between 0.25 mg/kg to 0.75 mg/kg is associated with more co-operative behaviour compared to placebo; standardised mean difference (SMD) favoured midazolam (SMD 2.98, 95% confidence interval (CI) 1.58 to 4.37, P < 0.001, I² = 91%), which translates to an increase of approximately 1.8 points on the six-point Houpt behaviour scale. There is very weak evidence from two trials which could not be pooled that inhalational nitrous oxide is more effective than placebo. AUTHORS' CONCLUSIONS: There is some weak evidence that oral midazolam is an effective sedative agent for children undergoing dental treatment. There is very weak evidence that nitrous oxide inhalation may also be effective. There is a need for further well designed and well reported clinical trials to evaluate other potential sedation agents. Further recommendations for future research are described and it is suggested that future trials evaluate experimental regimens in comparison with oral midazolam or inhaled nitrous oxide.

Interventions for the management of dry mouth: topical therapies.

BACKGROUND: Xerostomia (the feeling of dry mouth) is a common symptom especially in older adults. Causes of dry mouth include medications, autoimmune disease (Sjögren's Syndrome), radiotherapy or chemotherapy for cancer, hormone disorders and infections. OBJECTIVES: To determine which topical treatments for dry mouth are effective in reducing this symptom. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group Trials Register (28 October 2011), The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, Issue 4 2011), MEDLINE via OVID (1950 to 28 October 2011), EMBASE via OVID (1980 to 28 October 2011), CINAHL via EBSCO (1980 to 28 October 2011), AMED via OVID (1985 to 28 October 2011), CANCERLIT via PubMed (1950 to 28 October 2011). SELECTION CRITERIA: We included randomised controlled trials of topical interventions such as lozenges, sprays, mouthrinses, gels, oils, chewing gum or toothpastes for the treatment of dry mouth symptom. We classified interventions into two broad categories, saliva stimulants and saliva substitutes, and these were compared with either placebo or another intervention. We included both parallel group and crossover trials. DATA COLLECTION AND ANALYSIS: Two or more review authors independently carried out data extraction and assessed risk of bias. Trial authors were contacted for additional information as required. MAIN RESULTS: Thirty-six randomised controlled trials involving 1597 participants met the inclusion criteria. Two trials compared saliva stimulants to placebo, nine trials compared saliva substitutes to placebo, five trials compared saliva stimulants directly with saliva substitutes, 18 trials directly compared two or more saliva substitutes, and two trials directly compared two or more saliva stimulants. Only one trial was at low risk of bias and 17 were at high risk of bias. Due to the range of interventions, comparisons and outcome measures in the trials, meta-analysis was possible for only a few comparisons. Oxygenated glycerol triester (OGT) saliva substitute spray shows evidence of effectiveness compared to an electrolyte spray (standardised mean difference (SMD) 0.77, 95% confidence interval (CI) 0.38 to 1.15) which corresponds to approximately a mean difference of 2 points on a 10-point visual analogue scale (VAS) for mouth dryness. Both integrated mouthcare systems (toothpaste + gel + mouthwash) and oral reservoir devices show promising results but there is insufficient evidence at present to recommend their use. Although chewing gum is associated with increased saliva production in the majority of those with residual capacity, there is no evidence that gum is more or less effective than saliva substitutes. AUTHORS' CONCLUSIONS: There is no strong evidence from this review that any topical therapy is effective for relieving the symptom of dry mouth. OGT spray is more effective than an aqueous electrolyte spray (SMD 0.77, 95% CI 0.38 to 1.15) which is approximately equivalent to a mean difference of 2 points on a 10-point VAS scale for mouth dryness. Chewing gums appear to increase saliva production in those with residual secretory capacity and may be preferred by patients, but there is no evidence that gum is better or worse than saliva substitutes. Integrated mouthcare systems and oral reservoir devices may be helpful but further research is required to confirm this. Well designed, adequately powered randomised controlled trials of topical interventions for dry mouth, which are designed and reported according to CONSORT guidelines, are required to provide evidence to guide clinical care. For many people the symptom of dry mouth is a chronic problem and trials should evaluate whether treatments are palatable, effective in reducing xerostomia, as well as the long-term effects of treatments on quality of life of those with chronic dry mouth symptoms.

Interventions for the treatment of oral and oropharyngeal cancers: surgical treatment.

BACKGROUND: Surgery is an important part of the management of oral cavity cancer with regard to both the removal of the primary tumour and removal of lymph nodes in the neck. Surgery is less frequently used in oropharyngeal cancer. Surgery alone may be treatment for early stage disease or surgery may be used in combination with radiotherapy, chemotherapy and immunotherapy/biotherapy. There is variation in the recommended timing and extent of surgery in the overall treatment regimens of people with these cancers. OBJECTIVES: To determine which surgical treatment modalities for oral cavity and oropharyngeal cancers result in increased overall survival, disease free survival, progression free survival and reduced recurrence. SEARCH STRATEGY: The following electronic databases were searched: the Cochrane Oral Health Group Trials Register (to 17 February 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 1), MEDLINE via OVID (1950 to 17 February 2011) and EMBASE via OVID (1980 to 17 February 2011). There were no restrictions regarding language or date of publication. SELECTION CRITERIA: Randomised controlled trials where more than 50% of participants had primary tumours of the oral cavity or oropharynx, and which compared two or more surgical treatment modalities or surgery versus other treatment modalities. DATA COLLECTION AND ANALYSIS: Data extraction and assessment of risk of bias was undertaken independently by two or more review authors. Study authors were contacted for additional information as required. Adverse events data were collected from published trials. MAIN RESULTS: Seven trials (n = 669; 667 with cancers of the oral cavity) satisfied the inclusion criteria, but none were assessed as low risk of bias. Trials were grouped into three main comparisons. Four trials compared elective neck dissection (ND) with therapeutic neck dissection in patients with oral cavity cancer and clinically negative neck nodes, but differences in type of surgery and duration of follow-up made meta-analysis inappropriate. Three of these trials reported overall and disease free survival. One trial showed a benefit for elective supraomohyoid neck dissection compared to therapeutic ND in overall and disease free survival. Two trials found no difference between elective radical ND and therapeutic ND for the outcomes of overall survival and disease free survival. All four trials found reduced locoregional recurrence following elective ND.A further two trials compared elective radical ND with elective selective ND and found no difference in overall survival, disease free survival or recurrence. The final trial compared surgery plus radiotherapy to radiotherapy alone but data were unreliable because the trial stopped early and there were multiple protocol violations.None of the trials reported quality of life as an outcome. Two trials, evaluating different comparisons reported adverse effects of treatment. AUTHORS' CONCLUSIONS: Seven included trials evaluated neck dissection surgery in patients with oral cavity cancers. The review found weak evidence that elective neck dissection of clinically negative neck nodes at the time of removal of the primary tumour results in reduced locoregional recurrence, but there is insufficient evidence to conclude that elective neck dissection increases overall survival or disease free survival compared to therapeutic neck dissection. There is very weak evidence from one trial that elective supraomohyoid neck dissection may be associated with increased overall and disease free survival. There is no evidence that radical neck dissection increases overall survival compared to conservative neck dissection surgery. Reporting of adverse events in all trials was poor and it was not possible to compare the quality of life of patients undergoing different surgeries.

Interventions for treating oral lichen planus.

BACKGROUND: Oral lichen planus (OLP) is a common chronic autoimmune disease associated with cell-mediated immunological dysfunction. Symptomatic OLP is painful and complete healing is rare. OBJECTIVES: To assess the effectiveness and safety of any form of therapy for symptomatic OLP. SEARCH STRATEGY: The following electronic databases were searched: the Cochrane Oral Health Group Trials Register (to 26 January 2011), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 1), MEDLINE via OVID (1950 to 26 January 2011) and EMBASE via OVID (1980 to 26 January 2011). There were no restrictions regarding language or date of publication. SELECTION CRITERIA: All randomised controlled clinical trials (RCTs) of therapy for symptomatic OLP which compared treatment with a placebo or between treatments or no intervention were considered in this review. DATA COLLECTION AND ANALYSIS: The titles and abstracts of all reports identified were scanned independently by two review authors. All studies meeting the inclusion criteria were assessed for risk of bias and data were extracted. For dichotomous outcomes, the estimates of effects of an intervention were expressed as risk ratios (RR) together with 95% confidence intervals. For continuous outcomes, mean differences (MD) and 95% confidence intervals were used to summarise the data for each group. The statistical unit was the patient. Meta-analyses were done only with studies of similar comparisons reporting the same outcome measures. MAIN RESULTS: 28 trials were included in this review. Pain is the primary outcome of this review because it is the indication for treatment of OLP, and therefore this review indicates as effective, only those treatments which significantly reduce pain. Although topical steroids are considered first line treatment for symptomatic OLP, we identified no RCTs that compared steroids with placebo. There is no evidence from the three trials of pimecrolimus that this treatment is better than placebo in reducing pain from OLP. There is weak evidence from two trials, at unclear and high risk of bias respectively, that aloe vera may be associated with a reduction in pain compared to placebo, but it was not possible to pool the pain data from these trials. There is weak and unreliable evidence from two small trials, at high risk of bias, that cyclosporin may reduce pain and clinical signs of OLP, but meta-analysis of these trials was not possible.There were five trials that compared steroids with calcineurin inhibitors, each evaluating a different pair of interventions. There is no evidence from these trials that there is a difference between treatment with steroids compared to calcineurin inhibitors with regard to reducing pain associated with OLP. From six trials there is no evidence that any specific steroid therapy is more or less effective at reducing pain compared to another type or dose of steroid. AUTHORS' CONCLUSIONS: Although topical steroids are considered to be first line treatment, we identified no RCTs that compared steroids with placebo in patients with symptomatic OLP. From the trials in this review there is no evidence that one steroid is any more effective than another. There is weak evidence that aloe vera may reduce the pain of OLP and improve the clinical signs of disease compared to placebo. There is weak and unreliable evidence that cyclosporin may reduce pain and clinical signs of OLP. There is no evidence that other calcineurin inhibitors reduce pain compared to either steroids or placebo. From the 28 trials included in this systematic review, the wide range of interventions compared means there is insufficient evidence to support the effectiveness of any specific treatment as being superior.