Protocol for a Randomised controlled trial to Evaluate the effectiveness and cost benefit of prescribing high dose FLuoride toothpaste in preventing and treating dEntal Caries in high-risk older adulTs (reflect trial).

BACKGROUND: Dental caries in the expanding elderly, predominantly-dentate population is an emerging public health concern. Elderly individuals with heavily restored dentitions represent a clinical challenge and significant financial burden for healthcare systems, especially when their physical and cognitive abilities are in decline. Prescription of higher concentration fluoride toothpaste to prevent caries in older populations is expanding in the UK, significantly increasing costs for the National Health Services (NHS) but the effectiveness and cost benefit of this intervention are uncertain. The Reflect trial will evaluate the effectiveness and cost benefit of General Dental Practitioner (GDP) prescribing of 5000 ppm fluoride toothpaste and usual care compared to usual care alone in individuals 50 years and over with high-risk of caries. METHODS/DESIGN: A pragmatic, open-label, randomised controlled trial involving adults aged 50 years and above attending NHS dental practices identified by their dentist as having high risk of dental caries. Participants will be randomised to prescription of 5000 ppm fluoride toothpaste (frequency, amount and duration decided by GDP) and usual care only. 1200 participants will be recruited from approximately 60 dental practices in England, Scotland and Northern Ireland and followed up for 3 years. The primary outcome will be the proportion of participants receiving any dental treatment due to caries. Secondary outcomes will include coronal and root caries increments measured by independent, blinded examiners, patient reported quality of life measures, and economic outcomes; NHS and patient perspective costs, willingness to pay, net benefit (analysed over the trial follow-up period and modelled lifetime horizon). A parallel qualitative study will investigate GDPs' practises of and beliefs about prescribing the toothpaste and patients' beliefs and experiences of the toothpaste and perceived impacts on their oral health-related behaviours. DISCUSSION: The Reflect trial will provide valuable information to patients, policy makers and clinicians on the costs and benefits of an expensive, but evidence-deficient caries prevention intervention delivered to older adults in general dental practice. TRIAL REGISTRATION: ISRCTN: 2017-002402-13 registered 02/06/2017, first participant recruited 03/05/2018. Ethics Reference No: 17/NE/0329/233335. Funding Body: Health Technology Assessment funding stream of National Institute for Health Research. Funder number: HTA project 16/23/01. Trial Sponsor: Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL. The Trial was prospectively registered.

Open access to journal articles in oncology: current situation and citation impact.

BACKGROUND: Recent years have seen numerous efforts and resources devoted to the development of open access (OA), but the current OA situation of the oncology literature remains unknown. We conducted this cross-sectional study to determine the current share and provision methods of OA in the field of oncology, identify predictors of OA status (OA versus non-OA), and study the association between OA and citation counts. MATERIALS AND METHODS: PubMed was searched for oncology-related, peer-reviewed journal articles published in December 2014. Google, Google Scholar, PubMed, ResearchGate, OpenDOAR and OAIster were manually checked to assess the OA status of each included article. Citation data were extracted from Web of Science, Scopus and Google Scholar. Descriptive statistics were used to summarize the OA proportion (primary outcome) and OA provision methods. Multivariable logistic regression and multilevel generalized linear model analyses were performed to study predictors of OA status and the association between OA and citation counts, respectively. RESULTS: In a random sample of 1000 articles, 912 were deemed eligible and therefore included. Of these, the full-texts of 530 articles (58.1%; 95% CI: 54.9-61.3) were freely available online: 314 (34.4%) were available from publishers ('Gold road' to OA), 424 (46.5%) were available via self-archiving ('Green road' to OA). According to multivariable regression analyses, impact factor, publisher type, language, research type, number of authors, continent of origin, and country income were significant predictors of articles' OA status; OA articles received a citation rate 1.24 times the incidence rate for non-OA articles (95% CI: 1.05-1.47; P = 0.012). CONCLUSIONS: Based on our sample, in the field of oncology, 42% of recent journal articles are behind the pay-wall (non-OA) 1 year after publication; the 'Green road' of providing OA is more common than the 'Gold road'; OA is associated with higher citation counts.

A cross-sectional survey of 5-year-old children with non-syndromic unilateral cleft lip and palate: the Cleft Care UK study. Part 1: background and methodology.

OBJECTIVES: We describe the methodology for a major study investigating the impact of reconfigured cleft care in the United Kingdom (UK) 15 years after an initial survey, detailed in the Clinical Standards Advisory Group (CSAG) report in 1998, had informed government recommendations on centralization. SETTING AND SAMPLE POPULATION: This is a UK multicentre cross-sectional study of 5-year-olds born with non-syndromic unilateral cleft lip and palate. Children born between 1 April 2005 and 31 March 2007 were seen in cleft centre audit clinics. MATERIALS AND METHODS: Consent was obtained for the collection of routine clinical measures (speech recordings, hearing, photographs, models, oral health, psychosocial factors) and anthropometric measures (height, weight, head circumference). The methodology for each clinical measure followed those of the earlier survey as closely as possible. RESULTS: We identified 359 eligible children and recruited 268 (74.7%) to the study. Eleven separate records for each child were collected at the audit clinics. In total, 2666 (90.4%) were collected from a potential 2948 records. The response rates for the self-reported questionnaires, completed at home, were 52.6% for the Health and Lifestyle Questionnaire and 52.2% for the Satisfaction with Service Questionnaire. CONCLUSIONS: Response rates and measures were similar to those achieved in the previous survey. There are practical, administrative and methodological challenges in repeating cross-sectional surveys 15 years apart and producing comparable data.

Enamel Caries Detection and Diagnosis: An Analysis of Systematic Reviews.

Detection and diagnosis of caries-typically undertaken through a visual-tactile examination, often with supporting radiographic investigations-is commonly regarded as being broadly effective at detecting caries that has progressed into dentine and reached a threshold where restoration is necessary. With earlier detection comes an opportunity to stabilize disease or even remineralize the tooth surface, maximizing retention of tooth tissue and preventing a lifelong cycle of restoration. We undertook a formal comparative analysis of the diagnostic accuracy of different technologies to detect and inform the diagnosis of early caries using published Cochrane systematic reviews. Forming the basis of our comparative analysis were 5 Cochrane diagnostic test accuracy systematic reviews evaluating fluorescence, visual or visual-tactile classification systems, imaging, transillumination and optical coherence tomography, and electrical conductance or impedance technologies. Acceptable reference standards included histology, operative exploration, or enhanced visual assessment (with or without tooth separation) as appropriate. We conducted 2 analyses based on study design: a fully within-study, within-person analysis and a network meta-analysis based on direct and indirect comparisons. Nineteen studies provided data for the fully within-person analysis and 64 studies for the network meta-analysis. Of the 5 technologies evaluated, the greatest pairwise differences were observed in summary sensitivity points for imaging and all other technologies, but summary specificity points were broadly similar. For both analyses, the wide 95% prediction intervals indicated the uncertainty of future diagnostic accuracy across all technologies. The certainty of evidence was low, downgraded for study limitations, inconsistency, and indirectness. Summary estimates of diagnostic accuracy for most technologies indicate that the degree of certitude with which a decision is made regarding the presence or absence of disease may be enhanced with the use of such devices. However, given the broad prediction intervals, it is challenging to predict their accuracy in any future "real world" context.

Using Cochrane reviews for oral diseases.

OBJECTIVES: To provide readers with information about the Cochrane Oral Health Group and how the reviews on oral diseases have contributed to guideline developments and the commissioning of trials. MATERIALS AND METHODS: Examples have been selected from the reviews published on The Cochrane Library. Descriptions are given of how these reviews have been used in guideline development and commissioning of trials. Readers are updated on reviews focused on the management of oral cancer and the new venture of diagnostic test reviews. RESULTS: Reviews on the management of oral diseases due to cancer treatments have been included in guidelines and changed practice in the UK. Cochrane reviews on Bell's Palsy have led to a randomised controlled trial which has changed the evidence base. The Cochrane review on recall intervals between routine appointments has input into the NICE guideline and resulted in a randomised controlled trial to look at different intervals including a risk-based interval. CONCLUSION: We hope this article will give readers information on the work of the Cochrane Oral Health Group and insight into the diversity of reviews in oral diseases. The reviews are successfully being used to change practice and as background for the funding of large-scale clinical trials.

The impact of different viewing conditions on radiological file and working length measurement.

AIM: To determine the effect of different viewing conditions and observer experience upon the accuracy of file and working length measurements using analogue intra-oral radiographs. METHODOLOGY: Twenty-five observers from a range of clinical backgrounds examined working length analogue periapical radiographs of 30 extracted teeth. Each participant measured both file (FL) and working length (WL) on each of the radiographs using three different viewing conditions consisting of a viewing box, a viewing box with film masking and a viewing box with film masking and x2 magnification. Statistical analysis was conducted to derive interobserver reliability by intraclass correlation coefficients, and multiple linear regression models were fitted to compare the mean differences between the joint consensus between specialists and estimated values for file length and working length for each of the three viewing conditions. RESULTS: Multiple regressions models were fitted and found significant differences between the use of the viewing box alone and a viewing box with masking (FL P = 0.001; WL P < 0.001) and the use of the viewing box alone and with a viewing box employing masking and magnification (FL P < 0.001; WL P = 0.002). Intraclass correlation coefficient showed a high level of agreement between all observers; however, no statistically significant differences were found between the five observers groups for either mean file length or working length values. CONCLUSIONS: The results of this study are in agreement with National and European guidelines, which recommend the use of a viewing box, magnification and masking for radiographic interpretation.

Quality of Split-Mouth Trials in Dentistry: 1998, 2008, and 2018.

The objectives of this study were to assess the reporting quality and methodological quality of split-mouth trials (SMTs) published during the past 2 decades and to determine whether there has been an improvement in their quality over time. We searched the MEDLINE database via PubMed to identify SMTs published in 1998, 2008, and 2018. For each included SMT, we used the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 guideline, CONSORT for within-person trial (WPT) extension, and a new 3-item checklist to assess its trial reporting quality (TRQ), WPT-specific reporting quality (WRQ), and SMT-specific methodological quality (SMQ), respectively. Multivariable generalized linear models were performed to analyze the quality of SMTs over time, adjusting for potential confounding factors. A total of 119 SMTs were included. The mean overall score for the TRQ (score range, 0 to 32), WRQ (0 to 15), and SMQ (0 to 3) was 15.77 (SD 4.51), 6.06 (2.06), and 1.12 (0.70), respectively. The primary outcome was clearly defined in only 28 SMTs (23.5%), and only 27 (22.7%) presented a replicable sample size calculation. Only 45 SMTs (37.8%) provided the rationale for using a split-mouth design. The correlation between body sites was reported in only 5 studies (4.2%) for sample size calculation and 4 studies (3.4%) for statistical results. Only 2 studies (1.7%) performed an appropriate sample size calculation, and 46 (38.7%) chose appropriate statistical methods, both accounting for the correlation among treatment groups and the clustering/multiplicity of measurements within an individual. Results of regression analyses suggested that the TRQ of SMTs improved significantly with time (P < 0.001), while there was no evidence of improvement in WRQ or SMQ. Both the reporting quality and methodological quality of SMTs still have much room for improvement. Concerted efforts are needed to improve the execution and reporting of SMTs.

Interventions for replacing missing teeth: hyperbaric oxygen therapy for irradiated patients who require dental implants.

BACKGROUND: Dental implants offer one way to replace missing teeth. Patients who have undergone radiotherapy and those that have also undergone surgery for cancer in the head and neck region may benefit particularly from reconstruction with implants. Hyperbaric oxygen therapy (HBO) has been advocated to improve the success of implant treatment in patients who have undergone radiotherapy but this remains a controversial issue. OBJECTIVES: To compare success, morbidity, patient satisfaction and cost effectiveness of dental implant treatment carried out with and without HBO in irradiated patients. SEARCH STRATEGY: We searched the Cochrane Oral Health Group's Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE. Handsearching included several dental journals. We checked the bibliographies of relevant clinical trials and review articles for studies outside the handsearched journals. We wrote to authors of the identified randomised controlled trials (RCTs), to more than 55 oral implant manufacturers; we used personal contacts and we asked on an internet discussion group in an attempt to identify unpublished or ongoing RCTs. No language restriction was applied. The last electronic search was conducted on 13 June 2007. SELECTION CRITERIA: Randomised controlled trials of HBO therapy for irradiated patients requiring dental implants. DATA COLLECTION AND ANALYSIS: Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted in duplicate and independently by two review authors. Results were expressed as random-effects models using mean differences for continuous outcomes and risk ratios for dichotomous outcomes with 95% confidence intervals. MAIN RESULTS: Only one RCT was identified and included. Thirteen patients received HBO therapy while other 13 did not. Two to six implants were placed in fully edentulous mandibles to be rehabilitated with bar-retained overdentures. One year after implant loading four patients died from each group. One patient, treated with HBO, developed an osteoradionecrosis and lost all implants so the prosthesis could not be provided. Five patients in the HBO group had at least one implant failure versus two in the control group. There were no statistically significant differences for prosthesis and implant failures, postoperative complications and patient satisfaction between the two groups. AUTHORS' CONCLUSIONS: Despite the limited amount of clinical research available, it appears that HBO therapy in irradiated patients requiring dental implants may not offer any appreciable clinical benefits. There is a definite need for more RCTs to ascertain the effectiveness of HBO in irradiated patients requiring dental implants. These trials ought to be of a high quality and reported as recommended by the CONSORT statement (http://www.consort-statement.org/). Each clinical centre may have limited numbers of patients and it is likely that trials will need to be multicentred.

Full-mouth disinfection for the treatment of adult chronic periodontitis.

BACKGROUND: In an attempt to enhance treatment outcomes, alternative protocols for anti-infective periodontal therapy have been introduced. OBJECTIVES: To evaluate the effectiveness of full-mouth disinfection or full-mouth scaling compared to conventional quadrant scaling for periodontitis. SEARCH STRATEGY: Data sources included electronic databases, handsearched journals and contact with experts. The Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE were searched. Reference lists from relevant articles were scanned and the authors of eligible studies were contacted to identify trials and obtain additional information. Date of most recent searches: December 2006: (CENTRAL) (The Cochrane Library 2006, Issue 4). SELECTION CRITERIA: Randomised controlled trials were selected with at least 3 months follow up comparing full-mouth scaling and root planing within 24 hours with (FMD) or without (FMS) the adjunctive use of an antiseptic (chlorhexidine) with conventional quadrant scaling and root planing (control). The methodological quality of the studies was assessed within the data extraction form, mainly focusing on: method of randomisation, allocation concealment, blindness of examiners and completeness of follow up. DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment were conducted independently by multiple review authors. The primary outcome measure was tooth loss, secondary outcomes were reduction of probing depth, bleeding on probing and gain in probing attachment. The Cochrane Collaboration statistical guidelines were followed. MAIN RESULTS: The search identified 216 abstracts. Review of these abstracts resulted in 12 publications for detailed review. Finally, seven randomised controlled trials (RCTs) which met the criteria for eligibility were independently selected by two review authors. None of the studies included reported on tooth loss. All treatment modalities led to significant improvements in clinical parameters after a follow up of at least 3 months. For the secondary outcome, reduction in probing depth, the mean difference between FMD and control was 0.53 mm (95% confidence interval (CI) 0.28 to 0.77) in moderately deep pockets of single rooted teeth and for gain in probing attachment 0.33 mm (95% CI 0.04 to 0.62) in moderately deep single and multirooted teeth. Comparing FMD and FMS the mean difference in one study for gain in probing attachment amounted to 0.74 mm in favour of FMS (95% CI 0.17 to 1.31) for deep pockets in multirooted teeth, while another study reported a mean difference for reduction in bleeding on probing of 18% in favour of FMD (95% CI -33.74 to -2.26) for deep pockets of single rooted teeth. No significant differences were observed for any of the outcome measures, when comparing FMS and control. AUTHORS' CONCLUSIONS: In patients with chronic periodontitis in moderately deep pockets slightly more favourable outcomes for pocket reduction and gain in probing attachment were found following FMD compared to control. However, these additional improvements were only modest and there was only a very limited number of studies available for comparison, thus limiting general conclusions about the clinical benefit of full-mouth disinfection.

Interventions for replacing missing teeth: treatment of perimplantitis.

BACKGROUND: One of the key factors for the long-term success of oral implants is the maintenance of healthy tissues around them. Bacterial plaque accumulation induces inflammatory changes in the soft tissues surrounding oral implants and it may lead to their progressive destruction (perimplantitis) and ultimately to implant failure. Different treatment strategies for perimplantitis have been suggested, however it is unclear which are the most effective. OBJECTIVES: To identify the most effective interventions for treating perimplantitis around osseointegrated dental implants. SEARCH STRATEGY: We searched the Cochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE. Handsearching included several dental journals. We checked the bibliographies of the identified randomised controlled trials (RCTs) and relevant review articles for studies outside the handsearched journals. We wrote to authors of all identified RCTs, to more than 55 dental implant manufacturers and an Internet discussion group to find unpublished or ongoing RCTs. No language restrictions were applied. The last electronic search was conducted on 9 January 2008. SELECTION CRITERIA: All RCTs comparing agents or interventions for treating perimplantitis around dental implants. DATA COLLECTION AND ANALYSIS: Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted in duplicate and independently by two review authors. We contacted the authors for missing information. Results were expressed as random-effects models using weighted mean differences for continuous outcomes and risk ratios for dichotomous outcomes with 95% confidence intervals (CI). Heterogeneity was to be investigated including both clinical and methodological factors. MAIN RESULTS: Ten eligible trials were identified, but three were excluded. The following procedures were tested: (1) use of local antibiotics versus ultrasonic debridement; (2) benefits of adjunctive local antibiotics to debridement; (3) different techniques of subgingival debridement; (4) laser versus manual debridement and chlorhexidine irrigation/gel; (5) systemic antibiotics plus resective surgery plus two different local antibiotics with and without implant surface smoothening; and (6) nanocrystalline hydroxyapatite versus Bio-Oss and resorbable barriers. Follow up ranged from 3 months to 2 years. The only statistically significant differences were observed in two trials judged to be at high risk of bias. After 4 months, adjunctive local antibiotics to manual debridement in patients who lost at least 50% of the bone around implants showed improved mean probing attachment levels (PAL) of 0.61 mm and reduced probing pockets depths (PPD) of 0.59 mm. After 6 months, patients with perimplant infrabony defects > 3 mm treated with Bio-Oss and resorbable barriers gained 0.5 mm more PAL (borderline difference) and PPD than patients treated with a nanocrystalline hydroxyapatite. AUTHORS' CONCLUSIONS: There is very little reliable evidence suggesting which could be the most effective interventions for treating perimplantitis. This is not to say that currently used interventions are not effective. The use of local antibiotics in addition to manual subgingival debridement was associated with a 0.6 mm additional improvement for PAL and PPD over a 4-month period in patients affected by severe forms of perimplantitis. After 6 months both augmentation therapies appeared to be successful but improved PAL and PPD (0.5 mm) were obtained when using Bio-Oss with resorbable barriers. In four trials, the control therapy which basically consisted of a simple subgingival mechanical debridement seemed to be sufficient to achieve results similar to the more complex and expensive therapies. Sample sizes were very small and follow up too short, therefore these conclusions have to be considered with great caution. Larger well-designed RCTs are needed.

Interventions for replacing missing teeth: maintaining and recovering soft tissue health around dental implants.

BACKGROUND: It is important to institute an effective supportive therapy to maintain or recover soft tissue health around dental implants. Different maintenance regimens have been suggested, however it is unclear which are the most effective. OBJECTIVES: To test the null hypotheses of no difference between different interventions (1) for maintaining healthy peri-implant soft tissues, and (2) for recovering soft tissue health, against the alternative hypothesis of a difference. SEARCH STRATEGY: We searched the Cochrane Oral Health Group's Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE. Handsearching included several dental journals. We checked the bibliographies of the identified randomised controlled trials (RCTs) and relevant review articles for studies outside the handsearched journals. We wrote to authors of all identified RCTs, to more than 55 oral implant manufacturers and to an internet discussion group to find unpublished or ongoing RCTs. No language restrictions were applied. The last electronic search was conducted on 13 June 2007. SELECTION CRITERIA: All randomised controlled trials comparing agents or interventions for maintaining or recovering healthy tissues around dental implants. DATA COLLECTION AND ANALYSIS: Screening of eligible studies, assessment of the methodological quality of the trials and data extraction were conducted in duplicate and independently by two review authors. Results were expressed as random-effects models using standardised mean differences for continuous data and risk ratios for dichotomous data with 95% confidence intervals. MAIN RESULTS: Eighteen RCTs were identified. Nine of these trials, which reported results from a total of 238 patients, were included. Follow ups ranged between 6 weeks and 1 year. No meta-analysis could be made since every RCT tested different interventions. Listerine mouthwash showed a reduction of 54% in plaque and 34% in marginal bleeding compared with a placebo. Two trials evaluated the efficacy of powered and sonic toothbrushes compared to manual toothbrushing and showed no statistically significant differences, though more patients liked the sonic brush. No statistical differences were found between brushing with a hyaluronic or a chlorhexidine gel, between cleaning with an etching gel or manually, between injecting a chlorhexidine or a physiologic solution inside the implant's inner part and between submucosal minocycline and a chlorhexidine gel. When an amine fluoride/stannous fluoride (AmF/SnF(2)) mouthrinse was compared with a chlorhexidine one, no statistically significant differences were found for implant failures and staining index while patients preferred and had less taste change with the AmF/SnF(2) mouthrinse. Self administered subgingival chlorhexidine irrigation resulted in statistically significantly lower plaque and marginal bleeding than a chlorhexidine mouthwash, however the mouthwash was given at a suboptimal dosage. AUTHORS' CONCLUSIONS: There was only little reliable evidence for which are the most effective interventions for maintaining or recovering health of peri-implant soft tissues. The included RCTs had short follow-up periods and few subjects. There was not any reliable evidence for the most effective regimens for long term maintenance. This should not be interpreted as current maintenance regimens are ineffective. There was weak evidence that Listerine mouthwash, used twice a day for 30 seconds, as an adjunct to routine oral hygiene, is effective in reducing plaque and marginal bleeding around implants. More RCTs should be conducted in this area. In particular, there is a definite need for trials powered to find possible differences, using primary outcome measures and with much longer follow up. Such trials should be reported according to the CONSORT guidelines (http://www.consort-statement.org/).

Hyperlipidaemia due to carnitine palmitoyltransferase I deficiency.

We report a patient with carnitine palmitoyltransferase I (CPT I) deficiency, who presented with acute encephalopathy at 6 months of age. This was precipitated by an episode of gastroenteritis. No hypoglycaemia was documented, but there was hepatomegaly; blood tests revealed raised transaminases, a coagulopathy and severe hypertriglyceridaemia (48.8 mmol/L) and hypercholesterolaemia (9.5 mmol/L). The hyperlipidaemia resolved within 3 days of treatment and did not recur. At 2 years of age, the patient's liver function, growth and development are all normal. Hyperlipidaemia has been reported during acute illness in previous patients with CPT I deficiency but it is not a well-recognized feature; it should alert metabolic specialists to this potential diagnosis.

RCT comparing posterior occlusal forms for complete dentures.

Complete dentures can be produced with different types of occlusal forms. There is some evidence to suggest that it may be advantageous to provide complete dentures with cusped posterior teeth. The aim of this research was to compare the levels of subject satisfaction with 3 types of posterior occlusal forms for complete dentures, in a randomized cross-over trial design. Forty-five participants were randomly assigned 3 sets of complete dentures with different posterior occlusal forms (zero-degree, anatomic, and lingualized occlusions). Subjective data were collected according to visual analogue scales after 8 weeks of denture-wearing. Statistical analysis consisted of repeated-measures analysis of variance, followed by paired t tests. Lingualized and anatomic occlusal forms were perceived to be significantly superior in terms of chewing ability, when compared with zero-degree posterior occlusal surfaces.

Interventions for preventing oral candidiasis for patients with cancer receiving treatment.

BACKGROUND: Treatment of cancer is increasingly more effective but is associated with short and long term side effects. Oral side effects remain a major source of illness despite the use of a variety of agents to prevent and treat them. One of these side effects is oral candidiasis. OBJECTIVES: To assess the effectiveness of interventions (which may include placebo or no treatment) for the prevention of oral candidiasis for patients with cancer receiving chemotherapy or radiotherapy or both. SEARCH STRATEGY: Computerised searches of Cochrane Oral Health Group and PAPAS Trials Registers, CENTRAL, MEDLINE, EMBASE, CINAHL, CANCERLIT, SIGLE and LILACS were undertaken. Reference lists from relevant articles were searched and the authors of eligible trials were contacted to identify trials and obtain additional information. Date of the most recent searches: June 2006: CENTRAL (The Cochrane Library 2006, Issue 2). SELECTION CRITERIA: Trials were selected if they met the following criteria: design - random allocation of participants; participants - anyone receiving chemotherapy or radiotherapy treatment for cancer; interventions - agents prescribed to prevent oral candidiasis; primary outcome - prevention of oral candidiasis. DATA COLLECTION AND ANALYSIS: Data were recorded on the following secondary outcomes if present: relief of pain, amount of analgesia, relief of dysphagia, incidence of systemic infection, duration of stay in hospital (days), cost of oral care, patient quality of life, death, use of empirical antifungal treatment, toxicity and compliance. Information regarding methods, participants, interventions, outcome measures and results were independently extracted, in duplicate, by two review authors. The Cochrane Oral Health Group statistical guidelines were followed and risk ratios (RR) calculated using random-effects models. Potential sources of heterogeneity were examined in random-effects metaregression analyses. MAIN RESULTS: Twenty-eight trials involving 4226 patients satisfied the inclusion criteria. Drugs absorbed and partially absorbed from the gastrointestinal (GI) tract were found to prevent oral candidiasis when compared to a placebo, or a no treatment control group, with RR for absorbed drugs = 0.47 (95% confidence interval (CI) 0.29 to 0.78). For absorbed drugs in populations with an incidence of 20% (mid range of results in control groups), this implies a NNT of 9 (95% CI 7 to 13) patients need to be treated to avoid one patient getting oral candidiasis. There was no significant benefit shown for drugs not absorbed from the GI tract. AUTHORS' CONCLUSIONS: There is strong evidence, from randomised controlled trials, that drugs absorbed or partially absorbed from the GI tract prevent oral candidiasis in patients receiving treatment for cancer. There is also evidence that these drugs are significantly better at preventing oral candidiasis than drugs not absorbed from the GI.

Interventions for treating oral candidiasis for patients with cancer receiving treatment.

BACKGROUND: Treatment of cancer is increasingly effective but is associated with short and long term side effects. Oral side effects, including oral candidiasis, remain a major source of illness despite the use of a variety of agents to treat them. OBJECTIVES: To assess the effectiveness of interventions for the treatment of oral candidiasis for patients with cancer receiving chemotherapy or radiotherapy or both. SEARCH STRATEGY: Computerised searches of Cochrane Oral Health Group and PaPaS Trials Registers, CENTRAL, MEDLINE, EMBASE, CINAHL, CANCERLIT, SIGLE and LILACS were undertaken. Reference lists from relevant articles were searched and the authors of eligible trials were contacted to identify trials and obtain additional information. Date of the most recent searches: June 2006: CENTRAL (The Cochrane Library 2006, Issue 2). SELECTION CRITERIA: All randomised controlled trials comparing agents prescribed to treat oral candidiasis in people receiving chemotherapy or radiotherapy for cancer. The outcomes were eradication of oral candidiasis, dysphagia, systemic infection, amount of analgesia, length of hospitalisation, cost and patient quality of life. DATA COLLECTION AND ANALYSIS: Data were independently extracted, in duplicate, by two review authors. Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out. Risk ratios were calculated using random-effects models. MAIN RESULTS: Nine trials involving 658 patients, satisfied the inclusion criteria and are included in this review. Only two agents, each in single trials, were found to be effective for eradicating oral candidiasis. A drug absorbed from the gastrointestinal tract, ketoconazole, was more beneficial than placebo in eradicating oral candidiasis (risk ratio (RR) = 3.61, 95% confidence interval (CI) 1.47 to 8.88) and clotrimazole, at a higher dose of 50 mg was more effective than a lower 10 mg dose in eradicating oral candidiasis, when assessed mycologically (RR = 2.00, 95% CI 1.11 to 3.60). Of the five trials included in these meta-analyses, three were at high risk of bias and two of moderate risk of bias. Another trial demonstrated no statistically significant difference between a 10 mg dose of the partially absorbed drug, clotrimazole, and placebo. No differences were found when comparing different absorbed drugs; and comparing absorbed drugs with drugs which are not absorbed. AUTHORS' CONCLUSIONS: There is weak and unreliable evidence that the absorbed drug, ketoconazole, may eradicate oral candidiasis and that a higher dose of the partially absorbed drug, clotrimazole, may give greater benefit than a lower 10 mg dose, however, researchers may wish to prevent rather than treat oral candidiasis. Further well designed, placebo-controlled trials assessing the effectiveness of old and new interventions for treating oral candidiasis are needed.

Interventions for treating oral mucositis for patients with cancer receiving treatment.

BACKGROUND: Treatment of cancer is increasingly effective but associated with short and long term side effects. Oral side effects, including oral mucositis (mouth ulceration), remain a major source of illness despite the use of a variety of agents to treat them. OBJECTIVES: To assess the effectiveness of interventions for treating oral mucositis or its associated pain in patients with cancer receiving chemotherapy or radiotherapy or both. SEARCH STRATEGY: Computerised searches of Cochrane Oral Health Group's Trials Register; Cochrane Pain, Palliative and Supportive Care Group's Trials Register; CENTRAL; MEDLINE and EMBASE were undertaken. Reference lists from relevant articles were searched and the authors of eligible trials were contacted to identify trials and obtain additional information. Date of the most recent searches June 2006: CENTRAL (The Cochrane Library 2006, Issue 2). SELECTION CRITERIA: All randomised controlled trials comparing agents prescribed to treat oral mucositis in people receiving chemotherapy or radiotherapy or both. Outcomes were oral mucositis, time to heal mucositis, oral pain, duration of pain control, dysphagia, systemic infection, amount of analgesia, length of hospitalisation, cost and quality of life. DATA COLLECTION AND ANALYSIS: Data were independently extracted, in duplicate, by two review authors. Authors were contacted for details of randomisation, blindness and withdrawals. Quality assessment was carried out on these three criteria. The Cochrane Oral Health Group statistical guidelines were followed and risk ratio (RR) values calculated using fixed effect models. MAIN RESULTS: Twenty-six trials involving 1353 patients satisfied the inclusion criteria. Four agents, each in single trials, were found to be effective for improving (allopurinol RR 3.33, 95% confidence interval (CI) 1.06 to 10.49; granulocyte macrophage-colony stimulating factor RR 4.23, 95% CI 1.35 to 13.24; immunoglobulin RR 1.81, 95% CI 1.24 to 2.65; human placentral extract RR 4.50, 95% CI 2.29 to 8.86) or eradicating mucositis (allopurinol RR 19.00, 95% CI 1.17 to 307.63). Three of these trials were rated as at moderate risk of bias and one as at high risk of bias. The following agents were not found to be effective: benzydamine HCl, sucralfate, tetrachlorodecaoxide, chlorhexidine and 'magic' (lidocaine solution, diphenhydramine hydrochloride and aluminum hydroxide suspension). Six trials compared the time to heal and mucositis was found to heal more quickly with two interventions: granulocyte macrophage-colony stimulating factor when compared to povidone iodine, with mean difference -3.5 days (95% CI -4.1 to -2.9) and allopurinol compared to placebo, with mean difference -4.5 days (95% CI -5.8 to -3.2). Three trials compared patient controlled analgesia (PCA) to the continuous infusion method for controlling pain. There was no evidence of a difference, however, less opiate was used per hour for PCA, and the duration of pain was shorter. One trial demonstrated that pharmacokinetically based analgesia (PKPCA) reduced pain compared with PCA: however, more opiate was used with PKPCA. AUTHORS' CONCLUSIONS: There is weak and unreliable evidence that allopurinol mouthwash, granulocyte macrophage-colony stimulating factor, immunoglobulin or human placental extract improve or eradicate mucositis. There is no evidence that patient controlled analgesia (PCA) is better than continuous infusion method for controlling pain, however, less opiate was used per hour, and duration of pain was shorter, for PCA. Further, well designed, placebo-controlled trials assessing the effectiveness of allopurinol mouthwash, granulocyte macrophage-colony stimulating factor, immunoglobulin, human placental extract, other interventions investigated in this review and new interventions for treating mucositis are needed.

Pulp management for caries in adults: maintaining pulp vitality.

BACKGROUND: There is a range of treatment options for the management of the pulp in extensively decayed teeth. These include direct and indirect pulp capping, pulpotomy or pulpectomy. If the tooth is symptomatic or if there are periapical bone changes, then endodontic treatment is required. However, if the tooth is asymptomatic but the caries is extensive, there is no consensus as to the best method of management. In addition, there has been a recent move towards using alternative materials and methods such as the direct or indirect placement of bonding agents and mineral trioxide aggregate. Most studies have investigated the management of asymptomatic carious teeth with or without an exposed dental pulp using various capping materials (e.g. calcium hydroxide, Ledermix, Triodent, Biorex, etc.). However, there is no long term data regarding the outcome of management of asymptomatic, carious teeth according to different regimens. OBJECTIVES: This study aims to assess the effectiveness of techniques used to treat asymptomatic carious teeth and maintain pulp vitality. SEARCH STRATEGY: Electronic searches of the following databases were undertaken: The Cochrane Oral Health Group's Trials Register (March 2006), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2006, Issue 1), MEDLINE (1966 to week 4, February 2006), EMBASE (1974 to 13 March 2006), National Research Register (March 2006), Science Citation Index - SCISEARCH (1981 to March 2006). Detailed search strategies were developed for each database. Handsearching and screening of reference lists were undertaken. There was no restriction with regard to language of publication. SELECTION CRITERIA: Studies included were randomised controlled trials (RCTs). Asymptomatic vital permanent teeth with extensive caries were included. Studies were those which compared techniques to maintain pulp vitality. Outcome measures included clinical success and adverse events. DATA COLLECTION AND ANALYSIS: Data were independently extracted by three review authors. Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out. The Cochrane Oral Health Group's statistical guidelines were followed. MAIN RESULTS: Only four RCTs were identified. Interventions examined included: Ledermix, glycerrhetinic acid/antibiotic mix, zinc oxide eugenol, calcium hydroxide, Cavitec, Life, Dycal, potassium nitrate, dimethyl isosorbide, and polycarboxylate cement. Only one study showed a statistically significant finding; potassium nitrate/dimethyl isosorbide/polycarboxylate cement resulted in fewer clinical symptoms than potassium nitrate/polycarboxylate cement or polycarboxylate cement alone when used as a capping material for carious pulps. AUTHORS' CONCLUSIONS: It was disappointing that there were so few studies which could be considered as being suitable for inclusion in this review. The findings from this review do not suggest that there should be any significant change from accepted conventional practice procedures when the pulp of the carious tooth is considered. Further well designed RCTs are needed to investigate the potential of contemporary materials which may be suitable when used in the management of carious teeth. It is recognised that it is difficult to establish the 'ideal' clinical study when ethical approval for new materials must be sought and strict attention to case selection, study protocol and interpretation of data is considered. It is also not easy to recruit sufficient numbers of patients meeting the necessary criteria.

Interventions for preventing oral mucositis for patients with cancer receiving treatment.

BACKGROUND: Treatment of cancer is increasingly more effective but is associated with short and long term side effects. Oral side effects remain a major source of illness despite the use of a variety of agents to prevent them. One of these side effects is oral mucositis (mouth ulcers). OBJECTIVES: To evaluate the effectiveness of prophylactic agents for oral mucositis in patients with cancer receiving treatment, compared with other potentially active interventions, placebo or no treatment. SEARCH STRATEGY: The Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE were searched. Reference lists from relevant articles were scanned and the authors of eligible studies were contacted to identify trials and obtain additional information. Date of most recent searches: June 2006: CENTRAL (The Cochrane Library 2006, Issue 2). SELECTION CRITERIA: Trials were selected if they met the following criteria: design - random allocation of participants; participants - anyone with cancer receiving chemotherapy or radiotherapy treatment for cancer; interventions - agents prescribed to prevent oral mucositis; outcomes - prevention of mucositis, pain, amount of analgesia, dysphagia, systemic infection, length of hospitalisation, cost and patient quality of life. DATA COLLECTION AND ANALYSIS: Information regarding methods, participants, interventions and outcome measures and results were independently extracted, in duplicate, by two review authors. Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out. The Cochrane Collaboration statistical guidelines were followed and risk ratios (RR) calculated using random-effects models. MAIN RESULTS: Two hundred and seventy-seven studies were eligible. One hundred and eighty-eight were excluded for various reasons, usually as there was no useable information on mucositis. Of the 89 useable studies all had data for mucositis comprising 7523 randomised patients. Interventions evaluated were: acyclovir, allopurinol mouthrinse, aloe vera, antibiotic pastille or paste, benzydamine, beta carotene, calcium phosphate, camomile, Chinese medicine, chlorhexidine, etoposide, folinic acid, glutamine, granulocyte/macrophage colony-stimulating factor (GM-CSF), histamine gel, honey, hydrolytic enzymes, ice chips, iseganan, keratinocyte GF, misonidazole, pilocarpine, pentoxifylline, povidone, prednisone, propantheline anticholinergic, prostaglandin, sucralfate, systemic antibiotic clarithromycin, traumeel, zinc sulphate. Of the 33 interventions included in trials, 12 showed some evidence of a benefit (albeit sometimes weak) for either preventing or reducing the severity of mucositis. Interventions where there was more than one trial in the meta-analysis finding a significant difference when compared with a placebo or no treatment were: amifostine which provided minimal benefit in preventing mild and moderate mucositis RRs = 0.95 (95% confidence interval (CI) 0.92 to 0.98) and 0.88 (95% CI 0.80 to 0.98); Chinese medicine showed a benefit at all three dichotomies of mucositis with RR values of 0.44 (95% CI 0.20 to 0.96), 0.44 (95% CI 0.33 to 0.59) and 0.16 (95% CI 0.07 to 0.35) for increasing levels of mucositis severity; hydrolytic enzymes reduced moderate and severe mucositis with RRs = 0.52 (95% CI 0.36 to 0.74) and 0.17 (95% CI 0.06 to 0.52); and ice chips prevented mucositis at all levels RRs = 0.64 (95% CI 0.50 to 0.82), 0.38 (95% CI 0.23 to 0.62), and 0.24 (95% CI 0.12 to 0.48). Other interventions showing some benefit with only one study were: benzydamine, calcium phosphate, etoposide bolus, honey, iseganan, oral care, zinc sulphate. The general reporting of RCTs, especially concealment of randomisation, was poor. However, the assessments of the quality of the randomisation improved when the authors provided additional information. AUTHORS' CONCLUSIONS: Several of the interventions were found to have some benefit at preventing or reducing the severity of mucositis associated with cancer treatment. The strength of the evidence was variable and implications for practice include consideration that benefits may be specific for certain cancer types and treatment. There is a need for well designed and conducted trials with sufficient numbers of participants to perform subgroup analyses by type of disease and chemotherapeutic agent.

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 for almost 3 decades. Although recommendations regarding optimal recall intervals vary between countries and dental healthcare systems, 6-monthly dental check-ups have traditionally been advocated by general dental practitioners in many developed countries. OBJECTIVES: To determine the beneficial and harmful effects of different fixed recall intervals (for example 6 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 STRATEGY: We searched the Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE. Reference lists from relevant articles were scanned and the authors of some papers were contacted to identify further trials and obtain additional information. Date of most recent searches: 5th March 2007. SELECTION CRITERIA: Trials were selected if they met the following criteria: design - random allocation of participants; participants - all children and adults receiving dental check-ups in primary care settings, irrespective of their level of risk for oral disease; interventions - recall intervals for the following different types of dental check-ups: a) clinical examination only; b) clinical examination plus scale and polish; c) clinical examination plus preventive advice; d) clinical examination plus scale and polish plus preventive advice; e) no recall interval/patient driven attendance (which may be symptomatic); f) clinician risk-based recall intervals; outcomes - clinical status outcomes for dental caries (including, but not limited to, mean dmft/DMFT, dmfs/DMFS scores, caries increment, filled teeth (including replacement restorations), early carious lesions arrested or reversed); periodontal disease (including, but not limited to, plaque, calculus, gingivitis, periodontitis, change in probing depth, attachment level); oral mucosa (presence or absence of mucosal lesions, potentially malignant lesions, cancerous lesions, size and stage of cancerous lesions at diagnosis). In addition the following outcomes were considered where reported: patient-centred outcomes, economic cost outcomes, other outcomes such as improvements in oral health knowledge and attitudes, harms, changes in dietary habits and any other oral health-related behavioural change. DATA COLLECTION AND ANALYSIS: Information regarding methods, participants, interventions, outcome measures and results were independently extracted, in duplicate, by two review authors. Authors were contacted, where deemed necessary and where possible, for further details regarding study design and for data clarification. A quality assessment of the included trial was carried out. The Cochrane Collaboration's statistical guidelines were followed. MAIN RESULTS: Only one study (with 188 participants) was included in this review and was assessed as having a high risk of bias. This study provided limited data for dental caries outcomes (dmfs/DMFS increment) and economic cost outcomes (reported time taken to provide examinations and treatment). AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials (RCTs) to draw any conclusions regarding the potential beneficial and harmful effects of altering the recall interval between dental check-ups. There is insufficient evidence to support or refute the practice of encouraging patients to attend for dental check-ups at 6-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.