Development of a Root Caries Prediction Model in a Population of Dental Attenders.

Root caries prevalence is increasing as populations age and retain more of their natural dentition. However, there is generally no accepted practice to identify individuals at risk of disease. There is a need for the development of a root caries prediction model to support clinicians to guide targeted prevention strategies. The aim of this study was to develop a prediction model for root caries in a population of regular dental attenders. Clinical and patient-reported predictors were collected at baseline by routine clinical examination and patient questionnaires. Clinical examinations were conducted at the 4-year timepoint by trained outcome assessors blind to baseline data to record root caries data at two thresholds - root caries present on any teeth (RC > 0) and root caries present on three or more teeth (RC ≥ 3). Multiple logistic regression analyses were performed with the number of participants with root caries at each outcome threshold utilized as the outcome and baseline predictors as the candidate predictors. An automatic backwards elimination process was conducted to select predictors for the final model at each threshold. The sensitivity, specificity, and c-statistic of each model's performance was assessed. A total of 1,432 patient participants were included within this prediction model, with 324 (22.6%) presenting with at least one root caries lesion, and 97 (6.8%) with lesions on three or more teeth. The final prediction model at the RC >0 threshold included increasing age, having ≥9 restored teeth at baseline, smoking, lack of knowledge of spitting toothpaste without rinsing following toothbrushing, decreasing dental anxiety, and worsening OHRQoL. The model sensitivity was 71.4%, specificity 69.5%, and c-statistic 0.79 (95% CI: 0.76, 0.81). The predictors included in the final prediction model at the RC ≥ 3 threshold included increasing age, smoking, and lack of knowledge of spitting toothpaste without rinsing following toothbrushing. The model sensitivity was 76.5%, specificity 73.6%, and c-statistic 0.81 (95% CI: 0.77, 0.86). To the authors' knowledge, this is the largest published root caries prediction model, with statistics indicating good model fit and providing confidence in its robustness. The performance of the risk model indicates that adults at risk of developing root caries can be accurately identified, with superior performance in the identification of adults at risk of multiple lesions.

CORE OUTCOME SETS AND DENTAL PATIENT REPORTED OUTCOMES.

In clinical research, outcomes are the results or 'endpoints' that are measured to assess whether clinical interventions have been successful or whether one treatment works better than another. There are a vast number of outcomes that have been reported in dental trials; the number, diversity and questionable relevance of these outcomes can lead to research wastage. Ultimately, this can lead to uncertainty for patients and dental professionals as to the most effective prevention and treatment options available as the evidence available may not use outcomes important to them. This article introduces the reader to core outcome sets (COS), covering the background to this area of research; their purpose and role; as well as the methodology of development. The authors reflect on their experience of leading the development of a core outcome set for periodontal trials and we highlight other dental COSs already developed and their inclusion of dental Patient Reported Outcomes (dPROs).

Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care.

BACKGROUND: Dental caries is one of the most prevalent non-communicable disease globally and can have serious health sequelae impacting negatively on quality of life. In the UK most adults experience dental caries during their lifetime and the 2009 Adult Dental Health Survey reported that 85% of adults have at least one dental restoration. Conservative removal of tooth tissue for both primary and secondary caries reduces the risk of failure due to tooth-restoration, complex fracture as well as remaining tooth surfaces being less vulnerable to further caries. However, despite its prevalence there is no consensus on how much caries to remove prior to placing a restoration to achieve optimal outcomes. Evidence for selective compared to complete or near-complete caries removal suggests there may be benefits for selective removal in sustaining tooth vitality, therefore avoiding abscess formation and pain, so eliminating the need for more complex and costly treatment or eventual tooth loss. However, the evidence is of low scientific quality and mainly gleaned from studies in primary teeth. METHOD: This is a pragmatic, multi-centre, two-arm patient randomised controlled clinical trial including an internal pilot set in primary dental care in Scotland and England. Dental health professionals will recruit 623 participants over 12-years of age with deep carious lesions in their permanent posterior teeth. Participants will have a single tooth randomised to either the selective caries removal or complete caries removal treatment arm. Baseline measures and outcome data (during the 3-year follow-up period) will be assessed through clinical examination, patient questionnaires and NHS databases. A mixed-method process evaluation will complement the clinical and economic outcome evaluation and examine implementation, mechanisms of impact and context. The primary outcome at three years is sustained tooth vitality. The primary economic outcome is net benefit modelled over a lifetime horizon. Clinical secondary outcomes include pulp exposure, progession of caries, restoration failure; as well as patient-centred and economic outcomes. DISCUSSION: SCRiPT will provide evidence for the most clinically effective and cost-beneficial approach to managing deep carious lesions in permanent posterior teeth in primary care. This will support general dental practitioners, patients and policy makers in decision making. Trial Registration Trial registry: ISRCTN. TRIAL REGISTRATION NUMBER: ISRCTN76503940. Date of Registration: 30.10.2019. URL of trial registry record: https://www.isrctn.com/ISRCTN76503940?q=ISRCTN76503940%20&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search .

Cost-effectiveness of child caries management: a randomised controlled trial (FiCTION trial).

BACKGROUND: A three-arm parallel group, randomised controlled trial set in general dental practices in England, Scotland, and Wales was undertaken to evaluate three strategies to manage dental caries in primary teeth. Children, with at least one primary molar with caries into dentine, were randomised to receive Conventional with best practice prevention (C + P), Biological with best practice prevention (B + P), or best practice Prevention Alone (PA). METHODS: Data on costs were collected via case report forms completed by clinical staff at every visit. The co-primary outcomes were incidence of, and number of episodes of, dental pain and/or infection avoided. The three strategies were ranked in order of mean cost and a more costly strategy was compared with a less costly strategy in terms of incremental cost-effectiveness. Costs and outcomes were discounted at 3.5%. RESULTS: A total of 1144 children were randomised with data on 1058 children (C + P n = 352, B + P n = 352, PA n = 354) used in the analysis. On average, it costs £230 to manage dental caries in primary teeth over a period of up to 36 months. Managing children in PA was, on average, £19 (97.5% CI: -£18 to £55) less costly than managing those in B + P. In terms of effectiveness, on average, there were fewer incidences of, (- 0.06; 97.5% CI: - 0.14 to 0.02) and fewer episodes of dental pain and/or infection (- 0.14; 97.5% CI: - 0.29 to 0.71) in B + P compared to PA. C + P was unlikely to be considered cost-effective, as it was more costly and less effective than B + P. CONCLUSIONS: The mean cost of a child avoiding any dental pain and/or infection (incidence) was £330 and the mean cost per episode of dental pain and/or infection avoided was £130. At these thresholds B + P has the highest probability of being considered cost-effective. Over the willingness to pay thresholds considered, the probability of B + P being considered cost-effective never exceeded 75%. TRIAL REGISTRATION: The trial was prospectively registered with the ISRCTN (reference number ISRCTN77044005) on the 26th January 2009 and East of Scotland Research Ethics Committee provided ethical approved (REC reference: 12/ES/0047).

Slow-release fluoride devices for the control of dental decay.

BACKGROUND: Slow-release fluoride devices have been investigated as a potentially cost-effective method of reducing dental caries in people with high risk of disease. This is the second update of the Cochrane Review first published in 2006 and previously updated in 2014. OBJECTIVES: To evaluate the effectiveness and safety of different types of slow-release fluoride devices on preventing, arresting, or reversing the progression of carious lesions on all surface types of primary (deciduous) and permanent teeth. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following electronic databases: Cochrane Oral Health's Trials Register (to 23 January 2018); the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 12) in the Cochrane Library (searched 23 January 2018); MEDLINE Ovid (1946 to 23 January 2018); and Embase Ovid (1980 to 23 January 2018). The US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials (23 January 2018). We placed no restrictions on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: Parallel randomised controlled trials (RCTs) comparing slow-release fluoride devices with an alternative fluoride treatment, placebo, or no intervention in all age groups. The main outcome measures sought were changes in numbers of decayed, missing, and filled teeth or surfaces (DMFT/DMFS in permanent teeth or dmft/dmfs in primary teeth), and progression of carious lesions through enamel and into dentine. DATA COLLECTION AND ANALYSIS: We conducted data collection and analysis using standard Cochrane review methods. At least two review authors independently performed all the key steps in the review such as screening of abstracts, application of inclusion criteria, data extraction, and risk of bias assessment. We resolved discrepancies through discussions or arbitration by a third or fourth review author. MAIN RESULTS: We found no evidence comparing slow-release fluoride devices against other types of fluoride therapy.We found only one double-blind RCT involving 174 children comparing a slow-release fluoride device (glass beads with fluoride were attached to buccal surfaces of right maxillary first permanent molar teeth) against control (glass beads without fluoride were attached to buccal surfaces of right maxillary first permanent molar teeth). This study was assessed to be at high risk of bias. The study recruited children from seven schools in an area of deprivation that had low levels of fluoride in the water. The mean age at the beginning of the study was 8.8 years and at the termination was 10.9 years. DMFT in permanent teeth or dmft in primary teeth was greater than one at the start of the study and greater than one million colony-forming units of Streptococcus mutans per millilitre of saliva.Although 132 children were still included in the trial at the two-year completion point, examination and statistical analysis was performed on only the 63 children (31 in intervention group, 32 in control group) who had retained the beads (retention rate was 47.7% at 2 years). Among these 63 children, caries increment was reported to be statistically significantly lower in the intervention group than in the control group (DMFT: mean difference -0.72, 95% confidence interval (CI) -1.23 to -0.21; DMFS: mean difference -1.52, 95% CI -2.68 to -0.36 (very low-quality evidence)). Although this difference was clinically significant, it only holds true for those children who maintain the fluoride beads; over 50% of children did not retain the beads.Harms were not reported within the trial report. Evidence for other outcomes sought in this review (progression to of caries lesion, dental pain, healthcare utilisation data) were also not reported. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the caries-inhibiting effect of slow-release fluoride glass beads. The body of evidence available is of very low quality and there is a potential overestimation of benefit to the average child. The applicability of the findings to the wider population is unclear; the study had included children from a deprived area that had low levels of fluoride in drinking water, and were considered at high risk of caries. In addition, the evidence was only obtained from children who still had the bead attached at 2 years (48% of all available children); children who had lost their slow-release fluoride devices earlier might not have benefited as much from the devices.

INTERVAL (investigation of NICE technologies for enabling risk-variable-adjusted-length) dental recalls trial: a multicentre randomised controlled trial investigating the best dental recall interval for optimum, cost-effective maintenance of oral health in dentate adults attending dental primary care.

BACKGROUND: Traditionally, patients at low risk and high risk of developing dental disease have been encouraged to attend dental recall appointments at regular intervals of six months between appointments. The lack of evidence for the effect that different recall intervals between dental check-ups have on patient outcomes, provider workload and healthcare costs is causing considerable uncertainty for the profession and patients, despite the publication of the NICE Guideline on dental recall. The need for primary research has been highlighted in the Health Technology Assessment Group's systematic review of routine dental check-ups, which found little evidence to support or refute the practice of encouraging 6-monthly dental check-ups in adults. The more recent Cochrane review on recall interval concluded there was insufficient evidence to draw any conclusions regarding the potential beneficial or harmful effects of altering the recall interval between dental check-ups. There is therefore an urgent need to assess the relative effectiveness and cost-benefit of different dental recall intervals in a robust, sufficiently powered randomised control trial (RCT) in primary dental care. METHODS: This is a four year multi-centre, parallel-group, randomised controlled trial with blinded outcome assessment based in dental primary care in the UK. Practitioners will recruit 2372 dentate adult patients. Patient participants will be randomised to one of three groups: fixed-period six month recall, risk-based recall, or fixed-period twenty-four month recall. Outcome data will be assessed through clinical examination, patient questionnaires and NHS databases. The primary outcomes measure gingival inflammation/bleeding on probing and oral health-related quality of life. DISCUSSION: INTERVAL will provide evidence for the most clinically-effective and cost-beneficial recall interval for maintaining optimum oral health in dentate adults attending general dental practice. TRIAL REGISTRATION: ISRCTN95933794 (Date assigned 20/08/2008).

Interventions for preventing oral mucositis in patients with cancer receiving treatment: cytokines and growth factors.

BACKGROUND: Oral mucositis is a side effect of chemotherapy, head and neck radiotherapy, and targeted therapy, affecting over 75% of high-risk patients. Ulceration can lead to severe pain and difficulty with eating and drinking, which may necessitate opioid analgesics, hospitalisation and supplemental nutrition. These complications may disrupt cancer therapy, which may reduce survival. There is also a risk of death from sepsis if pathogens enter the ulcers of immunocompromised patients. Ulcerative oral mucositis can be costly to healthcare systems, yet there are few preventive interventions proven to be beneficial. Cytokines and growth factors may help the regeneration of cells lining of the mouth, thus preventing or reducing oral mucositis and its negative effects. OBJECTIVES: To assess the effects of cytokines and growth factors for preventing oral mucositis in patients with cancer who are receiving treatment. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (searched 10 May 2017); the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 4) in the Cochrane Library (searched 10 May 2017); MEDLINE Ovid (1946 to 10 May 2017); Embase Ovid (7 December 2015 to 10 May 2017); CINAHL EBSCO (Cumulative Index to Nursing and Allied Health Literature; 1937 to 10 May 2017); and CANCERLIT PubMed (1950 to 10 May 2017). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. SELECTION CRITERIA: We included parallel-design randomised controlled trials (RCTs) assessing the effects of cytokines and growth factors in patients with cancer receiving treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the results of electronic searches, extracted data and assessed risk of bias. For dichotomous outcomes, we reported risk ratios (RR) and 95% confidence intervals (CI). For continuous outcomes, we reported mean differences (MD) and 95% CIs. We pooled similar studies in random-effects meta-analyses. We reported adverse effects in a narrative format. MAIN RESULTS: We included 35 RCTs analysing 3102 participants. Thirteen studies were at low risk of bias, 12 studies were at unclear risk of bias, and 10 studies were at high risk of bias.Our main findings were regarding keratinocyte growth factor (KGF) and are summarised as follows.There might be a reduction in the risk of moderate to severe oral mucositis in adults receiving bone marrow/stem cell transplantation after conditioning therapy for haematological cancers (RR 0.89, 95% CI 0.80 to 0.99; 6 studies; 852 participants; low-quality evidence). We would need to treat 11 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 6 to 112). There might be a reduction in the risk of severe oral mucositis in this population, but there is also some possibility of an increase in risk (RR 0.85, 95% CI 0.65 to 1.11; 6 studies; 852 participants; low-quality evidence). We would need to treat 10 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 5 to prevent the outcome to 14 to cause the outcome).There is probably a reduction in the risk of moderate to severe oral mucositis in adults receiving radiotherapy to the head and neck with cisplatin or fluorouracil (RR 0.91, 95% CI 0.83 to 1.00; 3 studies; 471 participants; moderate-quality evidence). We would need to treat 12 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 7 to infinity). It is very likely that there is a reduction in the risk of severe oral mucositis in this population (RR 0.79, 95% CI 0.69 to 0.90; 3 studies; 471 participants; high-quality evidence). We would need to treat 7 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 5 to 15).It is likely that there is a reduction in the risk of moderate to severe oral mucositis in adults receiving chemotherapy alone for mixed solid and haematological cancers (RR 0.56, 95% CI 0.45 to 0.70; 4 studies; 344 participants; moderate-quality evidence). We would need to treat 4 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 3 to 6). There might be a reduction in the risk of severe oral mucositis in this population (RR 0.30, 95% CI 0.14 to 0.65; 3 studies; 263 participants; low -quality evidence). We would need to treat 10 adults with KGF in order to prevent one additional adult from developing this outcome (95% CI 8 to 19).Due to the low volume of evidence, single-study comparisons and insufficient sample sizes, we found no compelling evidence of a benefit for any other cytokines or growth factors and there was no evidence on children. There did not appear to be any serious adverse effects of any of the interventions assessed in this review. AUTHORS' CONCLUSIONS: We are confident that KGF is beneficial in the prevention of oral mucositis in adults who are receiving: a) radiotherapy to the head and neck with cisplatin or fluorouracil; or b) chemotherapy alone for mixed solid and haematological cancers. We are less confident about a benefit for KGF in adults receiving bone marrow/stem cell transplant after conditioning therapy for haematological cancers because of multiple factors involved in that population, such as whether or not they received total body irradiation (TBI) and whether the transplant was autologous (the patients' own cells) or allogeneic (cells from a donor). KGF appears to be a relatively safe intervention.Due to limited research, we are not confident that there are any beneficial effects of other cytokines and growth factors. There is currently insufficient evidence to draw any conclusions about the use of cytokines and growth factors in children.

An Audit and Feedback Intervention for Reducing Antibiotic Prescribing in General Dental Practice: The RAPiD Cluster Randomised Controlled Trial.

BACKGROUND: Dentists prescribe approximately 10% of antibiotics dispensed in UK community pharmacies. Despite clear clinical guidance, dentists often prescribe antibiotics inappropriately. This cluster-randomised controlled trial used routinely collected National Health Service (NHS) dental prescribing and treatment claim data to compare the impact of individualised audit and feedback (A&F) interventions on dentists' antibiotic prescribing rates. METHODS AND FINDINGS: All 795 antibiotic prescribing NHS general dental practices in Scotland were included. Practices were randomised to the control (practices = 163; dentists = 567) or A&F intervention group (practices = 632; dentists = 1,999). A&F intervention practices were allocated to one of two A&F groups: (1) individualised graphical A&F comprising a line graph plotting an individual dentist's monthly antibiotic prescribing rate (practices = 316; dentists = 1,001); or (2) individualised graphical A&F plus a written behaviour change message synthesising and reiterating national guidance recommendations for dental antibiotic prescribing (practices = 316; dentists = 998). Intervention practices were also simultaneously randomised to receive A&F: (i) with or without a health board comparator comprising the addition of a line to the graphical A&F plotting the monthly antibiotic prescribing rate of all dentists in the health board; and (ii) delivered at 0 and 6 mo or at 0, 6, and 9 mo, giving a total of eight intervention groups. The primary outcome, measured by the trial statistician who was blinded to allocation, was the total number of antibiotic items dispensed per 100 NHS treatment claims over the 12 mo post-delivery of the baseline A&F. Primary outcome data was available for 152 control practices (dentists = 438) and 609 intervention practices (dentists = 1,550). At baseline, the number of antibiotic items prescribed per 100 NHS treatment claims was 8.3 in the control group and 8.5 in the intervention group. At follow-up, antibiotic prescribing had decreased by 0.4 antibiotic items per 100 NHS treatment claims in control practices and by 1.0 in intervention practices. This represents a significant reduction (-5.7%; 95% CI -10.2% to -1.1%; p = 0.01) in dentists' prescribing rate in the intervention group relative to the control group. Intervention subgroup analyses found a 6.1% reduction in the antibiotic prescribing rate of dentists who had received the written behaviour change message relative to dentists who had not (95% CI -10.4% to -1.9%; p = 0.01). There was no significant between-group difference in the prescribing rate of dentists who received a health board comparator relative to those who did not (-4.3%; 95% CI -8.6% to 0.1%; p = 0.06), nor between dentists who received A&F at 0 and 6 mo relative to those who received A&F at 0, 6, and 9 mo (0.02%; 95% CI -4.2% to 4.2%; p = 0.99). The key limitations relate to the use of routinely collected datasets which did not allow evaluation of any effects on inappropriate prescribing. CONCLUSIONS: A&F derived from routinely collected datasets led to a significant reduction in the antibiotic prescribing rate of dentists. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49204710.

Fluoride Varnish for Caries Prevention: Efficacy and Implementation.

Many reviews support fluoride varnish (FV) as a caries-inhibitory agent. Evidence from 6 Cochrane systematic reviews involving 200 trials and more than 80,000 participants further confirms the effectiveness of FV, applied professionally 2-4 times a year, for preventing dental caries in both primary and permanent teeth. The relative benefit of FV application seems to occur irrespective of baseline caries risk, baseline caries severity, background exposure to fluorides, use of fluoride toothpaste and application features such as prior prophylaxis, concentration of fluoride or frequency of application. While the efficacy of FV is acknowledged in clinical practice guidelines globally, the implementation of this recommendation may still be an issue. Factors that may facilitate FV application in the USA include Medicaid eligibility, relationships with dentists/community centers and strong cooperation and communication between physicians and support staff. Barriers include insufficient time to integrate oral health services into well-child visits, difficulty in applying FV (lack of skills/training) and resistance among colleagues and staff. Research in the UK/Scotland also suggests encouraging clinicians in their motivation to perform this treatment and addressing professional and parental concerns relating to possible negative consequences may be influential. Further research targeting cost-effectiveness and how FV in routine care may fit in with political agendas relating to, for example, inequalities in health care provision and access will also play a key part in stakeholder decisions to put resources into this issue.

Interventions for preventing oral mucositis in patients with cancer receiving treatment: oral cryotherapy.

BACKGROUND: Oral mucositis is a side effect of chemotherapy, head and neck radiotherapy, and targeted therapy, affecting over 75% of high risk patients. Ulceration can lead to severe pain and difficulty eating and drinking, which may necessitate opioid analgesics, hospitalisation and nasogastric or intravenous nutrition. These complications may lead to interruptions or alterations to cancer therapy, which may reduce survival. There is also a risk of death from sepsis if pathogens enter the ulcers of immunocompromised patients. Ulcerative oral mucositis can be costly to healthcare systems, yet there are few preventive interventions proven to be beneficial. Oral cryotherapy is a low-cost, simple intervention which is unlikely to cause side-effects. It has shown promise in clinical trials and warrants an up-to-date Cochrane review to assess and summarise the international evidence. OBJECTIVES: To assess the effects of oral cryotherapy for preventing oral mucositis in patients with cancer who are receiving treatment. SEARCH METHODS: We searched the following databases: the Cochrane Oral Health Group Trials Register (to 17 June 2015), the Cochrane Central Register of Controlled Trials (CENTRAL) (Cochrane Library 2015, Issue 5), MEDLINE via Ovid (1946 to 17 June 2015), EMBASE via Ovid (1980 to 17 June 2015), CANCERLIT via PubMed (1950 to 17 June 2015) and CINAHL via EBSCO (1937 to 17 June 2015). We searched the US National Institutes of Health Trials Registry, and the WHO Clinical Trials Registry Platform for ongoing trials. No restrictions were placed on the language or date of publication when searching databases. SELECTION CRITERIA: We included parallel-design randomised controlled trials (RCTs) assessing the effects of oral cryotherapy in patients with cancer receiving treatment. We used outcomes from a published core outcome set registered on the COMET website. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the results of electronic searches, extracted data and assessed risk of bias. We contacted study authors for information where feasible. For dichotomous outcomes, we reported risk ratios (RR) and 95% confidence intervals (CI). For continuous outcomes, we reported mean differences (MD) and 95% CIs. We pooled similar studies in random-effects meta-analyses. We reported adverse effects in a narrative format. MAIN RESULTS: We included 14 RCTs analysing 1280 participants. The vast majority of participants did not receive radiotherapy to the head and neck, so this review primarily assesses prevention of chemotherapy-induced oral mucositis. All studies were at high risk of bias. The following results are for the main comparison: oral cryotherapy versus control (standard care or no treatment). Adults receiving fluorouracil-based (5FU) chemotherapy for solid cancersOral cryotherapy probably reduces oral mucositis of any severity (RR 0.61, 95% CI 0.52 to 0.72, 5 studies, 444 analysed, moderate quality evidence). In a population where 728 per 1000 would develop oral mucositis, oral cryotherapy would reduce this to 444 (95% CI 379 to 524). The number needed to treat to benefit one additional person (NNTB), i.e. to prevent them from developing oral mucositis, is 4 people (95% CI 3 to 5).The results were similar for moderate to severe oral mucositis (RR 0.52, 95% CI 0.41 to 0.65, 5 studies, 444 analysed, moderate quality evidence). NNTB 4 (95% CI 4 to 6).Severe oral mucositis is probably reduced (RR 0.40, 95% CI 0.27 to 0.61, 5 studies, 444 analysed, moderate quality evidence). Where 300 per 1000 would develop severe oral mucositis, oral cryotherapy would reduce this to 120 (95% CI 81 to 183), NNTB 6 (95% CI 5 to 9). Adults receiving high-dose melphalan-based chemotherapy before haematopoietic stem cell transplantation (HSCT)Oral cryotherapy may reduce oral mucositis of any severity (RR 0.59, 95% CI 0.35 to 1.01, 5 studies, 270 analysed, low quality evidence). Where 824 per 1000 would develop oral mucositis, oral cryotherapy would reduce this to 486 (95% CI reduced to 289 to increased to 833). The NNTB is 3, although the uncertainty surrounding the effect estimate means that the 95% CI ranges from 2 NNTB, to 111 NNTH (number needed to treat in order to harm one additional person, i.e. for one additional person to develop oral mucositis).The results were similar for moderate to severe oral mucositis (RR 0.43, 95% CI 0.17 to 1.09, 5 studies, 270 analysed, low quality evidence). NNTB 3 (95% CI 2 NNTB to 17 NNTH).Severe oral mucositis is probably reduced (RR 0.38, 95% CI 0.20 to 0.72, 5 studies, 270 analysed, moderate quality evidence). Where 427 per 1000 would develop severe oral mucositis, oral cryotherapy would reduce this to 162 (95% CI 85 to 308), NNTB 4 (95% CI 3 to 9).Oral cryotherapy was shown to be safe, with very low rates of minor adverse effects, such as headaches, chills, numbness/taste disturbance, and tooth pain. This appears to contribute to the high rates of compliance seen in the included studies.There was limited or no evidence on the secondary outcomes of this review, or on patients undergoing other chemotherapies, radiotherapy, targeted therapy, or on comparisons of oral cryotherapy with other interventions or different oral cryotherapy regimens. Therefore no further robust conclusions can be made. There was also no evidence on the effects of oral cryotherapy in children undergoing cancer treatment. AUTHORS' CONCLUSIONS: We are confident that oral cryotherapy leads to large reductions in oral mucositis of all severities in adults receiving 5FU for solid cancers. We are less confident in the ability of oral cryotherapy to reduce oral mucositis in adults receiving high-dose melphalan before HSCT. Evidence suggests that it does reduce oral mucositis in these adults, but we are less certain about the size of the reduction, which could be large or small. However, we are confident that there is an appreciable reduction in severe oral mucositis in these adults.This Cochrane review includes some very recent and currently unpublished data, and strengthens international guideline statements for adults receiving the above cancer treatments.

Water fluoridation for the prevention of dental caries.

BACKGROUND: Dental caries is a major public health problem in most industrialised countries, affecting 60% to 90% of school children. Community water fluoridation was initiated in the USA in 1945 and is currently practised in about 25 countries around the world; health authorities consider it to be a key strategy for preventing dental caries. Given the continued interest in this topic from health professionals, policy makers and the public, it is important to update and maintain a systematic review that reflects contemporary evidence. OBJECTIVES: To evaluate the effects of water fluoridation (artificial or natural) on the prevention of dental caries.To evaluate the effects of water fluoridation (artificial or natural) on dental fluorosis. SEARCH METHODS: We searched the following electronic databases: The Cochrane Oral Health Group's Trials Register (to 19 February 2015); The Cochrane Central Register of Controlled Trials (CENTRAL; Issue 1, 2015); MEDLINE via OVID (1946 to 19 February 2015); EMBASE via OVID (1980 to 19 February 2015); Proquest (to 19 February 2015); Web of Science Conference Proceedings (1990 to 19 February 2015); ZETOC Conference Proceedings (1993 to 19 February 2015). We searched the US National Institutes of Health Trials Registry (ClinicalTrials.gov) and the World Health Organization's WHO International Clinical Trials Registry Platform for ongoing trials. There were no restrictions on language of publication or publication status in the searches of the electronic databases. SELECTION CRITERIA: For caries data, we included only prospective studies with a concurrent control that compared at least two populations - one receiving fluoridated water and the other non-fluoridated water - with outcome(s) evaluated at at least two points in time. For the assessment of fluorosis, we included any type of study design, with concurrent control, that compared populations exposed to different water fluoride concentrations. We included populations of all ages that received fluoridated water (naturally or artificially fluoridated) or non-fluoridated water. DATA COLLECTION AND ANALYSIS: We used an adaptation of the Cochrane 'Risk of bias' tool to assess risk of bias in the included studies.We included the following caries indices in the analyses: decayed, missing and filled teeth (dmft (deciduous dentition) and DMFT (permanent dentition)), and proportion caries free in both dentitions. For dmft and DMFT analyses we calculated the difference in mean change scores between the fluoridated and control groups. For the proportion caries free we calculated the difference in the proportion caries free between the fluoridated and control groups.For fluorosis data we calculated the log odds and presented them as probabilities for interpretation. MAIN RESULTS: A total of 155 studies met the inclusion criteria; 107 studies provided sufficient data for quantitative synthesis.The results from the caries severity data indicate that the initiation of water fluoridation results in reductions in dmft of 1.81 (95% CI 1.31 to 2.31; 9 studies at high risk of bias, 44,268 participants) and in DMFT of 1.16 (95% CI 0.72 to 1.61; 10 studies at high risk of bias, 78,764 participants). This translates to a 35% reduction in dmft and a 26% reduction in DMFT compared to the median control group mean values. There were also increases in the percentage of caries free children of 15% (95% CI 11% to 19%; 10 studies, 39,966 participants) in deciduous dentition and 14% (95% CI 5% to 23%; 8 studies, 53,538 participants) in permanent dentition. The majority of studies (71%) were conducted prior to 1975 and the widespread introduction of the use of fluoride toothpaste.There is insufficient information to determine whether initiation of a water fluoridation programme results in a change in disparities in caries across socioeconomic status (SES) levels.There is insufficient information to determine the effect of stopping water fluoridation programmes on caries levels.No studies that aimed to determine the effectiveness of water fluoridation for preventing caries in adults met the review's inclusion criteria.With regard to dental fluorosis, we estimated that for a fluoride level of 0.7 ppm the percentage of participants with fluorosis of aesthetic concern was approximately 12% (95% CI 8% to 17%; 40 studies, 59,630 participants). This increases to 40% (95% CI 35% to 44%) when considering fluorosis of any level (detected under highly controlled, clinical conditions; 90 studies, 180,530 participants). Over 97% of the studies were at high risk of bias and there was substantial between-study variation. AUTHORS' CONCLUSIONS: There is very little contemporary evidence, meeting the review's inclusion criteria, that has evaluated the effectiveness of water fluoridation for the prevention of caries.The available data come predominantly from studies conducted prior to 1975, and indicate that water fluoridation is effective at reducing caries levels in both deciduous and permanent dentition in children. Our confidence in the size of the effect estimates is limited by the observational nature of the study designs, the high risk of bias within the studies and, importantly, the applicability of the evidence to current lifestyles. The decision to implement a water fluoridation programme relies upon an understanding of the population's oral health behaviour (e.g. use of fluoride toothpaste), the availability and uptake of other caries prevention strategies, their diet and consumption of tap water and the movement/migration of the population. There is insufficient evidence to determine whether water fluoridation results in a change in disparities in caries levels across SES. We did not identify any evidence, meeting the review's inclusion criteria, to determine the effectiveness of water fluoridation for preventing caries in adults.There is insufficient information to determine the effect on caries levels of stopping water fluoridation programmes.There is a significant association between dental fluorosis (of aesthetic concern or all levels of dental fluorosis) and fluoride level. The evidence is limited due to high risk of bias within the studies and substantial between-study variation.

Slow-release fluoride devices for the control of dental decay.

BACKGROUND: Slow-release fluoride devices have been investigated as a potentially cost-effective method of reducing dental caries in people with high risk of disease. OBJECTIVES: To evaluate the effectiveness and safety of different types of slow-release fluoride devices on preventing, arresting, or reversing the progression of carious lesions on all surface types of primary (deciduous) and permanent teeth. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group Trials Register (to 13 August 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 7), MEDLINE via Ovid (1946 to 13 August 2014), and EMBASE via Ovid (1980 to 13 August 2014). We searched the US National Institutes of Health Trials Register and the World Health Organization (WHO) International Clinical Trials Registry Platform. We placed no restrictions on the language or date of publication when searching the electronic databases.We first published the review in 2006. The update in 2013 found 302 abstracts, but none of these met the inclusion criteria of the review. SELECTION CRITERIA: Parallel randomised controlled trials (RCTs) comparing slow-release fluoride devices with an alternative fluoride treatment, placebo, or no intervention in all age groups. The main outcomes measures sought were changes in numbers of decayed, missing, and filled teeth or surfaces (DMFT/DMFS in permanent teeth or dmft/dmfs in primary teeth), and progression of carious lesions through enamel and into dentine. DATA COLLECTION AND ANALYSIS: We conducted data collection and analysis using standard Cochrane review methods. At least two review authors independently performed all the key steps in the review such as screening of abstracts, application of inclusion criteria, data extraction, and risk of bias assessment. We resolved discrepancies through discussions or arbitration by a third or fourth review author. MAIN RESULTS: We found no evidence comparing slow-release fluoride devices against other types of fluoride therapy.We found only one double-blind RCT involving 174 children comparing a slow-release fluoride device (glass beads with fluoride were attached to buccal surfaces of right maxillary first permanent molar teeth) against control (glass beads without fluoride were attached to buccal surfaces of right maxillary first permanent molar teeth). This study was assessed to be at high risk of bias. The study recruited children from seven schools in an area of deprivation that had low levels of fluoride in the water. The mean age at the beginning of the study was 8.8 years and at the termination was 10.9 years. DMFT in permanent teeth or dmft in primary teeth was greater than one at the start of the study and greater than one million colony-forming units of Streptococcus mutans per millilitre of saliva.Although 132 children were still included in the trial at the two-year completion point, examination and statistical analysis was performed on only the 63 children (31 in intervention group, 32 in control group) who had retained the beads (retention rate was 47.7% at two years). Among these 63 children, caries increment was reported to be statistically significantly lower in the intervention group than in the control group (DMFT: mean difference -0.72, 95% confidence interval (CI) -1.23 to -0.21; DMFS: mean difference -1.52, 95% CI -2.68 to -0.36 (very low quality evidence)). Although this difference was clinically significant, it only holds true for those children who maintain the fluoride beads; over 50% of children did not retain the beads.Harms were not reported within the trial report. Evidence for other outcomes sought in this review (progression to of caries lesion, dental pain, healthcare utilisation data) were also not reported. AUTHORS' CONCLUSIONS: There is insufficeint evidence to determine the caries-inhibiting effect of slow-release fluoride glass beads. The body of evidence available is of very low quality and there is a potential overestimation of benefit to the average child. The applicability of the findings to the wider population is unclear; the study had included children from a deprived area that had low levels of fluoride in drinking water, and were considered at high risk of carries. In addition, the evidence was only obtained from children who still had the bead attached at two years (48% of all available children); children who had lost their slow-release fluoride devices earlier might not have benefited as much from the devices.

Fluoride varnishes for preventing dental caries in children and adolescents.

BACKGROUND: Topically-applied fluoride varnishes have been used extensively as an operator-applied caries-preventive intervention for over three decades. This review updates the first Cochrane review of fluoride varnishes for preventing dental caries in children and adolescents, which was first published in 2002. OBJECTIVES: To determine the effectiveness and safety of fluoride varnishes in preventing dental caries in children and adolescents, and to examine factors potentially modifying their effect. SEARCH METHODS: We searched the Cochrane Oral Health Group's Trials Register (to 13 May 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 4), MEDLINE via OVID (1946 to 13 May 2013), EMBASE via OVID (1980 to 13 May 2013), CINAHL via EBSCO (1980 to 13 May 2013), LILACS and BBO via the BIREME Virtual Health Library (1980 to 13 May 2013), ProQuest Dissertations and Theses (1861 to 13 May 2013), and Web of Science Conference Proceedings (1945 to 13 May 2013). A search for ongoing trials was undertaken on ClinicalTrials.gov on 13 May 2013. There were no restrictions on language or date of publication in the search of the electronic databases. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials with blind outcome assessment used or indicated, comparing topically-applied fluoride varnish with placebo or no treatment in children up to 16 years during at least one year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces in both permanent (D(M)FS) and primary (d(e/m)fs) teeth. DATA COLLECTION AND ANALYSIS: At least two review authors assessed all search results, extracted data and undertook risk of bias independently. Study authors were contacted for additional information. The primary measure of effect was the prevented fraction, that is the difference in mean caries increments between the treatment and control groups expressed as a percentage of the mean increment in the control group. The caries increments nearest to three years were used from each included study. Random-effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random-effects meta-regression analyses. Adverse effects information was collected from the included trials. MAIN RESULTS: Twenty-two trials with 12,455 participants randomised (9595 used in analyses) were included. For the 13 that contributed data for the permanent tooth surfaces meta-analysis, the pooled D(M)FS prevented fraction estimate comparing fluoride varnish with placebo or no treatment was 43% (95% confidence interval (CI) 30% to 57%; P < 0.0001). There was substantial heterogeneity, confirmed statistically (P < 0.0001; I(2) = 75%), however this body of evidence was assessed as of moderate quality. The pooled d(e/m)fs prevented fraction estimate was 37% (95% CI 24% to 51%; P < 0.0001) for the 10 trials that contributed data for the primary tooth surfaces meta-analysis, also with some heterogeneity (P = 0.009; I(2) = 59%). Once again this body of evidence was assessed as of moderate quality. No significant association between estimates of D(M)FS or d(e/m)fs prevented fractions and the pre-specified factors of baseline caries severity, background exposure to fluorides, application features such as prior prophylaxis, concentration of fluoride, frequency of application were found. There was also no significant association between estimates of D(M)FS or d(e/m)fs prevented fractions and the post hoc factors: whether a placebo or no treatment control was used, length of follow-up, or whether individual or cluster randomisation was used, in the meta-regression models. A funnel plot of the trials in the main meta-analyses indicated no clear relationship between prevented fraction and study precision. In both methods, power is limited when few trials are included. There was little information concerning possible adverse effects or acceptability of treatment. AUTHORS' CONCLUSIONS: The conclusions of this updated review remain the same as those when it was first published. The review suggests a substantial caries-inhibiting effect of fluoride varnish in both permanent and primary teeth, however the quality of the evidence was assessed as moderate, as it included mainly high risk of bias studies, with considerable heterogeneity.

Routine scale and polish for periodontal health in adults.

BACKGROUND: Many dentists or hygienists provide scaling and polishing for patients at regular intervals, even if those patients are considered to be at low risk of developing periodontal disease. There is debate over the clinical effectiveness and cost effectiveness of 'routine scaling and polishing' and the 'optimal' frequency at which it should be provided for healthy adults.A 'routine scale and polish' treatment is defined as scaling or polishing or both of the crown and root surfaces of teeth to remove local irritational factors (plaque, calculus, debris and staining), that does not involve periodontal surgery or any form of adjunctive periodontal therapy such as the use of chemotherapeutic agents or root planing. OBJECTIVES: The objectives were: 1) to determine the beneficial and harmful effects of routine scaling and polishing for periodontal health; 2) to determine the beneficial and harmful effects of providing routine scaling and polishing at different time intervals on periodontal health; 3) to compare the effects of routine scaling and polishing with or without oral hygiene instruction (OHI) on periodontal health; and 4) to compare the effects of routine scaling and polishing provided by a dentist or dental care professional (dental therapist or dental hygienist) on periodontal health. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 15 July 2013), CENTRAL (The Cochrane Library 2013, Issue 6), MEDLINE via OVID (1946 to 15 July 2013) and EMBASE via OVID (1980 to 15 July 2013). We searched the metaRegister of Controlled Trials and the US National Institutes of Health Clinical Trials Register (clinicaltrials.gov) for ongoing and completed studies to July 2013. There were no restrictions regarding language or date of publication. SELECTION CRITERIA: Randomised controlled trials of routine scale and polish treatments (excluding split-mouth trials) with and without OHI in healthy dentate adults, without severe periodontitis. DATA COLLECTION AND ANALYSIS: Two review authors screened the results of the searches against inclusion criteria, extracted data and assessed risk of bias independently and in duplicate. We calculated mean differences (MDs) (standardised mean differences (SMDs) when different scales were reported) and 95% confidence intervals (CIs) for continuous data and, where results were meta-analysed, we used a fixed-effect model as there were fewer than four studies. Study authors were contacted where possible and where deemed necessary for missing information. MAIN RESULTS: Three studies were included in this review with 836 participants included in the analyses. All three studies are assessed as at unclear risk of bias. The numerical results are only presented here for the primary outcome gingivitis. There were no useable data presented in the studies for the outcomes of attachment change and tooth loss. No studies reported any adverse effects.- Objective 1: Scale and polish versus no scale and polish Only one trial provided data for the comparison between scale and polish versus no scale and polish. This study was conducted in general practice and compared both six-monthly and 12-monthly scale and polish treatments with no treatment. This study showed no evidence to claim or refute benefit for scale and polish treatments for the outcomes of gingivitis, calculus and plaque. The MD for six-monthly scale and polish, for the percentage of index teeth with bleeding at 24 months was -2% (95% CI -10% to 6%; P value = 0.65), with 40% of the sites in the control group with bleeding. The MD for 12-monthly scale and polish was -1% (95% CI -9% to 7%; P value = 0.82). The body of evidence was assessed as of low quality.- Objective 2: Scale and polish at different time intervals Two studies, both at unclear risk of bias, compared routine scale and polish provided at different time intervals. When comparing six with 12 months there was insufficient evidence to determine a difference for gingivitis at 24 months SMD -0.08 (95% CI -0.27 to 0.10). There were some statistically significant differences in favour of scaling and polishing provided at more frequent intervals, in particular between three and 12 months for the outcome of gingivitis at 24 months, with OHI, MD -0.14 (95% CI -0.23 to -0.05; P value = 0.003) and without OHI MD -0.21 (95% CI -0.30 to -0.12; P value < 0.001) (mean per patient measured on 0-3 scale), based on one study. There was some evidence of a reduction in calculus. This body of evidence was assessed as of low quality.- Objective 3: Scale and polish with and without OHIOne study provided data for the comparison of scale and polish treatment with and without OHI. There was a reduction in gingivitis for the 12-month scale and polish treatment when assessed at 24 months MD -0.14 (95% CI -0.22 to -0.06) in favour of including OHI. There were also significant reductions in plaque for both three and 12-month scale and polish treatments when OHI was included. The body of evidence was once again assessed as of low quality.- Objective 4: Scale and polish provided by a dentist compared with a dental care professionalNo studies were found which compared the effects of routine scaling and polishing provided by a dentist or dental care professional (dental therapist or dental hygienist) on periodontal health. AUTHORS' CONCLUSIONS: There is insufficient evidence to determine the effects of routine scale and polish treatments. High quality trials conducted in general dental practice settings with sufficiently long follow-up periods (five years or more) are required to address the objectives of this review.

Recall intervals for oral health in primary care patients.

BACKGROUND: The frequency with which patients should attend for a dental check-up and the potential effects on oral health of altering recall intervals between check-ups have been the subject of ongoing international debate in recent decades. Although recommendations regarding optimal recall intervals vary between countries and dental healthcare systems, six-monthly dental check-ups have traditionally been advocated by general dental practitioners in many developed countries.This is an update of a Cochrane review first published in 2005, and previously updated in 2007. OBJECTIVES: To determine the beneficial and harmful effects of different fixed recall intervals (for example six months versus 12 months) for the following different types of dental check-up: a) clinical examination only; b) clinical examination plus scale and polish; c) clinical examination plus preventive advice; d) clinical examination plus preventive advice plus scale and polish.To determine the relative beneficial and harmful effects between any of these different types of dental check-up at the same fixed recall interval.To compare the beneficial and harmful effects of recall intervals based on clinicians' assessment of patients' disease risk with fixed recall intervals.To compare the beneficial and harmful effects of no recall interval/patient driven attendance (which may be symptomatic) with fixed recall intervals. SEARCH METHODS: The following electronic databases were searched: the Cochrane Oral Health Group's Trials Register (to 27 September 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 9), MEDLINE via OVID (1946 to 27 September 2013) and EMBASE via OVID (1980 to 27 September 2013). We searched the US National Institutes of Health Trials Register (http://clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (http://www.who.int/ictrp/en/) for ongoing trials. Reference lists from relevant articles were scanned and the authors of some papers were contacted to identify further trials and obtain additional information. We did not apply any restrictions regarding language or date of publication when searching the electronic databases. SELECTION CRITERIA: We included randomised controlled trials (RCTs) assessing the effects of different dental recall intervals. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the search results against the inclusion criteria of the review, extracted data and carried out risk of bias assessment. We contacted study authors for clarification or further information where necessary and feasible. If we had found more than one study with similar comparisons reporting the same outcomes, we would have combined the studies in a meta-analysis using a random-effects model if there were at least four studies, or a fixed-effect model if there were less than four studies. We expressed the estimate of effect as mean difference with 95% confidence intervals (CIs) for continuous outcomes. We would have used risk ratios with 95% CI for any dichotomous outcomes. MAIN RESULTS: We included one study that analysed 185 participants. The study compared the effects of a clinical examination every 12 months with a clinical examination every 24 months on the outcomes of caries (decayed, missing, filled surfaces (dmfs/DMFS) increment) and economic cost outcomes (total time used per person). As the study was at high risk of bias, had a small sample size and only included low-risk participants, we rated the quality of the body of evidence for these outcomes as very low.For three to five-year olds with primary teeth, the mean difference (MD) in dmfs increment was -0.90 (95% CI -1.96 to 0.16) in favour of 12-month recall. For 16 to 20-year olds with permanent teeth, the MD in DMFS increment was -0.86 (95% CI -1.75 to 0.03) also in favour of 12-month recall. There is insufficient evidence to determine whether 12 or 24-month recall with clinical examination results in better caries outcomes.For three to five-year olds with primary teeth, the MD in time used by each participant was 10 minutes (95% CI -6.7 to 26.7) in favour of 24-month recall. For 16 to 20-year olds with permanent teeth, the MD was 23.7 minutes (95% CI 4.12 to 43.28) also in favour of 24-month recall. This single study at high risk of bias represents insufficient evidence to determine whether 12 or 24-month recall with clinical examination results in better time/cost outcomes. AUTHORS' CONCLUSIONS: There is a very low quality body of evidence from one RCT which is insufficient to draw any conclusions regarding the potential beneficial and harmful effects of altering the recall interval between dental check-ups. There is no evidence to support or refute the practice of encouraging patients to attend for dental check-ups at six-monthly intervals. It is important that high quality RCTs are conducted for the outcomes listed in this review in order to address the objectives of this review.

Operative caries management in adults and children.

BACKGROUND: The management of dental caries has traditionally involved removal of all soft demineralised dentine before a filling is placed. However, the benefits of complete caries removal have been questioned because of concerns about the possible adverse effects of removing all soft dentine from the tooth. Three groups of studies have also challenged the doctrine of complete caries removal by sealing caries into teeth using three different techniques. The first technique removes caries in stages over two visits some months apart, allowing the dental pulp time to lay down reparative dentine (the stepwise excavation technique). The second removes part of the dentinal caries and seals the residual caries into the tooth permanently (partial caries removal) and the third technique removes no dentinal caries prior to sealing or restoring (no dentinal caries removal). This is an update of a Cochrane review first published in 2006. OBJECTIVES: To assess the effects of stepwise, partial or no dentinal caries removal compared with complete caries removal for the management of dentinal caries in previously unrestored primary and permanent teeth. SEARCH METHODS: The following electronic databases were searched: the Cochrane Oral Health Group's Trials Register (to 12 December 2012), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 11), MEDLINE via OVID (1946 to 12 December 2012) and EMBASE via OVID (1980 to 12 December 2012). There were no restrictions regarding language or date of publication. SELECTION CRITERIA: Parallel group and split-mouth randomised and quasi-randomised controlled trials comparing stepwise, partial or no dentinal caries removal with complete caries removal, in unrestored primary and permanent teeth were included. DATA COLLECTION AND ANALYSIS: Three review authors extracted data independently and in triplicate and assessed risk of bias. Trial authors were contacted where possible for information. We used standard methodological procedures exacted by The Cochrane Collaboration. MAIN RESULTS: In this updated review, four new trials were included bringing the total to eight trials with 934 participants and 1372 teeth. There were three comparisons: stepwise caries removal compared to complete one stage caries removal (four trials); partial caries removal compared to complete caries removal (three trials) and no dentinal caries removal compared to complete caries removal (two trials). (One three-arm trial compared complete caries removal to both stepwise and partial caries removal.) Four studies investigated primary teeth, three permanent teeth and one included both. All of the trials were assessed at high risk of bias, although the new trials showed evidence of attempts to minimise bias.Stepwise caries removal resulted in a 56% reduction in incidence of pulp exposure (risk ratio (RR) 0.44, 95% confidence interval (CI) 0.33 to 0.60, P < 0.00001, I(2) = 0%) compared to complete caries removal based on moderate quality evidence, with no heterogeneity. In these four studies, the mean incidence of pulp exposure was 34.7% in the complete caries removal group and 15.4% in the stepwise groups. There was also moderate quality evidence of no difference in the outcome of signs and symptoms of pulp disease (RR 0.78, 95% CI 0.39 to 1.58, P = 0.50, I(2) = 0%).Partial caries removal reduced incidence of pulp exposure by 77% compared to complete caries removal (RR 0.23, 95% CI 0.08 to 0.69, P = 0.009, I(2) = 0%), also based on moderate quality evidence with no evidence of heterogeneity. In these two studies the mean incidence of pulp exposure was 21.9% in the complete caries removal groups and 5% in the partial caries removal groups. There was insufficient evidence to determine whether or not there was a difference in signs and symptoms of pulp disease (RR 0.27, 95% CI 0.05 to 1.60, P = 0.15, I(2) = 0%, low quality evidence), or restoration failure (one study showing no difference and another study showing no failures in either group, very low quality evidence).No dentinal caries removal was compared to complete caries removal in two very different studies. There was some moderate evidence of no difference between these techniques for the outcome of signs and symptoms of pulp disease and reduced risk of restoration failure favouring no dentinal caries removal, from one study, and no instances of pulp disease or restoration failure in either group from a second quasi-randomised study. Meta-analysis of these two studies was not performed due to substantial clinical differences between the studies. AUTHORS' CONCLUSIONS: Stepwise and partial excavation reduced the incidence of pulp exposure in symptomless, vital, carious primary as well as permanent teeth. Therefore these techniques show clinical advantage over complete caries removal in the management of dentinal caries. There was no evidence of a difference in signs or symptoms of pulpal disease between stepwise excavation, and complete caries removal, and insufficient evidence to determine whether or not there was a difference in signs and symptoms of pulp disease between partial caries removal and complete caries removal. When partial caries removal was carried out there was also insufficient evidence to determine whether or not there is a difference in risk of restoration failure. The no dentinal caries removal studies investigating permanent teeth had a similar result with no difference in restoration failure. The other no dentinal caries removal study, which investigated primary teeth, showed a statistically significant difference in restoration failure favouring the intervention.Due to the short term follow-up in most of the included studies and the high risk of bias, further high quality, long term clinical trials are still required to assess the most effective intervention. However, it should be noted that in studies of this nature, complete elimination of risk of bias may not necessarily be possible. Future research should also investigate patient centred outcomes.

Interdental brushing for the prevention and control of periodontal diseases and dental caries in adults.

BACKGROUND: Effective oral hygiene is a crucial factor in maintaining good oral health, which is associated with overall health and health-related quality of life. Dental floss has been used for many years in conjunction with toothbrushing for removing dental plaque in between teeth, however, interdental brushes have been developed which many people find easier to use than floss, providing there is sufficient space between the teeth. OBJECTIVES: To evaluate the effects of interdental brushing in addition to toothbrushing, as compared with toothbrushing alone or toothbrushing and flossing for the prevention and control of periodontal diseases, dental plaque and dental caries. SEARCH METHODS: We searched the following electronic databases: the Cochrane Oral Health Group's Trials Register (to 7 March 2013), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 2), MEDLINE via OVID (1946 to 7 March 2013), EMBASE via OVID (1980 to 7 March 2013), CINAHL via EBSCO (1980 to 7 March 2013), LILACS via BIREME (1982 to 7 March 2013), ZETOC Conference Proceedings (1980 to 7 March 2013) and Web of Science Conference Proceedings (1990 to 7 March 2013). We searched the US National Institutes of Health Trials Register (http://clinicaltrials.gov) and the metaRegister of Controlled Trials (http://www.controlled-trials.com/mrct/) for ongoing trials to 7 March 2013. No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: We included randomised controlled trials (including split-mouth design, cross-over and cluster-randomised trials) of dentate adult patients. The interventions were a combination of toothbrushing and any interdental brushing procedure compared with toothbrushing only or toothbrushing and flossing. DATA COLLECTION AND ANALYSIS: At least two review authors assessed each of the included studies to confirm eligibility, assessed risk of bias and extracted data using a piloted data extraction form. We calculated standardised mean difference (SMD) and 95% confidence interval (CI) for continuous outcomes where different scales were used to assess an outcome. 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 seven studies (total 354 participants analysed) included in this review. We assessed one study as being low, three studies as being high and three studies as being at unclear risk of bias. Studies only reported the clinical outcome gingivitis and plaque data, with no studies providing data on many of the outcomes: periodontitis, caries, halitosis and quality of life. Three studies reported that no adverse events were observed or reported during the study. Two other studies provided some data on adverse events but we were unable to pool the data due to lack of detail. Two studies did not report whether adverse events occurred. Interdental brushing in addition to toothbrushing, as compared with toothbrushing alone Only one high risk of bias study (62 participants in analysis) looked at this comparison and there was very low-quality evidence for a reduction in gingivitis (0 to 4 scale, mean in control): mean difference (MD) 0.53 (95% CI 0.23 to 0.83) and plaque (0 to 5 scale): MD 0.95 (95% CI 0.56 to 1.34) at one month, favouring of use of interdental brushes. This represents a 34% reduction in gingivitis and a 32% reduction in plaque. Interdental brushing in addition to toothbrushing, as compared with toothbrushing and flossing Seven studies provided data showing a reduction in gingivitis in favour of interdental brushing at one month: SMD -0.53 (95% CI -0.81 to -0.24, seven studies, 326 participants, low-quality evidence). This translates to a 52% reduction in gingivitis (Eastman Bleeding Index). Although a high effect size in the same direction was observed at three months (SMD -1.98, 95% CI -5.42 to 1.47, two studies, 107 participants, very low quality), the confidence interval was wide and did not exclude the possibility of no difference. There was insufficient evidence to claim a benefit for either interdental brushing or flossing for reducing plaque (SMD at one month 0.10, 95% CI -0.13 to 0.33, seven studies, 326 participants, low-quality evidence) and insufficient evidence at three months (SMD -2.14, 95% CI -5.25 to 0.97, two studies, 107 participants very low-quality evidence). AUTHORS' CONCLUSIONS: Only one study looked at whether toothbrushing with interdental brushing was better than toothbrushing alone, and there was very low-quality evidence for a reduction in gingivitis and plaque at one month. There is also low-quality evidence from seven studies that interdental brushing reduces gingivitis when compared with flossing, but these results were only found at one month. There was insufficient evidence to determine whether interdental brushing reduced or increased levels of plaque when compared to flossing.

The FiCTION dental trial protocol - filling children's teeth: indicated or not?

BACKGROUND: There is a lack of evidence for effective management of dental caries (decay) in children's primary (baby) teeth and an apparent failure of conventional dental restorations (fillings) to prevent dental pain and infection for UK children in Primary Care. UK dental schools' teaching has been based on British Society of Paediatric Dentistry guidance which recommends that caries in primary teeth should be removed and a restoration placed. However, the evidence base for this is limited in volume and quality, and comes from studies conducted in either secondary care or specialist practices. Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been questioned. The FiCTION trial addresses the Health Technology Assessment (HTA) Programme's commissioning brief and research question "What is the clinical and cost effectiveness of restoration caries in primary teeth, compared to no treatment?" It compares conventional restorations with an intermediate treatment strategy based on the biological (sealing-in) management of caries and with no restorations. METHODS/DESIGN: This is a Primary Care-based multi-centre, three-arm, parallel group, patient-randomised controlled trial. Practitioners are recruiting 1461 children, (3-7 years) with at least one primary molar tooth where caries extends into dentine. Children are randomized and treated according to one of three treatment approaches; conventional caries management with best practice prevention, biological management of caries with best practice prevention or best practice prevention alone. Baseline measures and outcome data (at review/treatment during three year follow-up) are assessed through direct reporting, clinical examination including blinded radiograph assessment, and child/parent questionnaires. The primary outcome measure is the incidence of either pain or infection related to dental caries. Secondary outcomes are; incidence of caries in primary and permanent teeth, patient quality of life, cost-effectiveness, acceptability of treatment strategies to patients and parents and their experiences, and dentists' preferences. DISCUSSION: FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children's primary teeth in Primary Care. This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth. The trial is currently recruiting patients. TRIAL REGISTRATION: Protocol ID: NCTU: ISRCTN77044005.

IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care.

BACKGROUND: Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered necessary to prevent and treat periodontal disease thereby maintaining periodontal health. Despite evidence of an association between sustained, good oral hygiene and a low incidence of periodontal disease and caries in adults there is a lack of strong and reliable evidence to inform clinicians of the relative effectiveness (if any) of different types of Oral Hygiene Advice (OHA). The evidence to inform clinicians of the effectiveness and optimal frequency of PI is also mixed. There is therefore an urgent need to assess the relative effectiveness of OHA and PI in a robust, sufficiently powered randomised controlled trial (RCT) in primary dental care. METHODS/DESIGN: This is a 5 year multi-centre, randomised, open trial with blinded outcome evaluation based in dental primary care in Scotland and the North East of England. Practitioners will recruit 1860 adult patients, with periodontal health, gingivitis or moderate periodontitis (Basic Periodontal Examination Score 0-3). Dental practices will be cluster randomised to provide routine OHA or Personalised OHA. To test the effects of PI each individual patient participant will be randomised to one of three groups: no PI, 6 monthly PI (current practice), or 12 monthly PI.Baseline measures and outcome data (during a three year follow-up) will be assessed through clinical examination, patient questionnaires and NHS databases.The primary outcome measures at 3 year follow up are gingival inflammation/bleeding on probing at the gingival margin; oral hygiene self-efficacy and net benefits. DISCUSSION: IQuaD will provide evidence for the most clinically-effective and cost-effective approach to managing periodontal disease in dentate adults in Primary Care. This will support general dental practitioners and patients in treatment decision making. TRIAL REGISTRATION: Protocol ID: ISRCTN56465715.

A Review of Aerosol Generation Mitigation in International Dental Guidance.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) led to the worldwide closure of dental practices or reduction of dental services. By the end of April 2020, governments and professional organisations were publishing recommendations or guidance for the reopening/restructuring of dental services. The aim of this study was to assess how dental aerosol-generating procedures (AGPs) were defined in international dental guidelines, what mitigation processes were advised, and whether they were linked to COVID-19 epidemiology. METHODS: Electronic searches of a broad range of databases, along with grey literature searches, without language restriction were conducted up to 13 July 2020. Recommendations for the use of face masks and fallow times with patients without COVID-19 were assessed against the deaths per 1 million population in the included countries and country income level using Pearson Chi-squared statistics. RESULTS: Sixty-three guidance documents were included. Most (98%) indicated that AGPs can be performed with patients without COVID-19 with caveats, including advice to restrict AGPs where possible, with 21% only recommending AGPs for dental emergencies. Face masks were recommended by most documents (94%), with 91% also specifying the use of goggles or face shields. Fallow periods for patients without COVID-19 were mentioned in 48% of documents, ranging from 2 to 180 minutes. There were no significant differences in recommendations for face masks or fallow time in patients without COVID-19 by country death rate (P = .463 and P = .901) or World Bank status (P = .504 and P = .835). Most documents recommended procedural or environmental mitigations such as preprocedural mouthwash (82%) and general ventilation (52%). Few documents provided underpinning evidence for their recommendations. CONCLUSIONS: While the amount of high-quality direct evidence related to dentistry and COVID-19 remains limited, it is important to be explicit about the considered judgements for recommendations as well as generate new evidence to face this challenge.