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.

Cost-Effectiveness of Caries Prevention in Practice: A Randomized Controlled Trial.

A 2-arm parallel-group randomized controlled trial measured the cost-effectiveness of caries prevention in caries-free children aged 2 to 3 y attending general practice. The setting was 22 dental practices in Northern Ireland. Participants were centrally randomized into intervention (22,600 ppm fluoride varnish, toothbrush, a 50-mL tube of 1,450 ppm fluoride toothpaste, and standardized prevention advice) and control (advice only), both provided at 6-monthly intervals during a 3-y follow-up. The primary outcome measure was conversion from caries-free to caries-active states assessed by calibrated and blinded examiners; secondary outcome measures included decayed, missing, or filled teeth surfaces (dmfs); pain; and extraction. Cumulative costs were related to each of the trial's outcomes in a series of incremental cost effectiveness ratios (ICERs). Sensitivity analyses examined the impact of using dentist's time as measured by observation rather than that reported by the dentist. The costs of applying topical fluoride were also estimated assuming the work was undertaken by dental nurses or hygienists rather than dentists. A total of 1,248 children (624 randomized to each group) were recruited, and 1,096 (549 in the intervention group and 547 in the control group) were included in the final analyses. The mean difference in direct health care costs between groups was £107.53 (£155.74 intervention, £48.21 control, P < 0.05) per child. When all health care costs were compared, the intervention group's mean cost was £212.56 more than the control group (£987.53 intervention, £774.97 control, P < 0.05). Statistically significant differences in outcomes were only detected with respect to carious surfaces. The mean cost per carious surface avoided was estimated at £251 (95% confidence interval, £454.39-£79.52). Sensitivity analyses did not materially affect the study's findings. This trial raises concerns about the cost-effectiveness of a fluoride-based intervention delivered at the practice level in the context of a state-funded dental service (EudraCT No: 2009-010725-39; ISRCTN: ISRCTN36180119).

A Randomized Controlled Trial of Caries Prevention in Dental Practice.

We conducted a parallel group randomized controlled trial of children initially aged 2 to 3 y who were caries free, to prevent the children becoming caries active over the subsequent 36 mo. The setting was 22 dental practices in Northern Ireland, and children were randomly assigned by a clinical trials unit (CTU) (using computer-generated random numbers, with allocation concealed from the dental practice until each child was recruited) to the intervention (22,600-ppm fluoride varnish, toothbrush, 50-mL tube of 1,450 ppm fluoride toothpaste, and standardized, evidence-based prevention advice) or advice-only control at 6-monthly intervals. The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were number of decayed, missing, or filled teeth (dmfs) in caries-active children, number of episodes of pain, and number of extracted teeth. Adverse reactions were recorded. Calibrated external examiners, blinded to the child's study group, assessed the status of the children at baseline and after 3 y. In total, 1,248 children (624 randomized to each group) were recruited, and 1,096 (549 intervention, 547 control) were included in the final analyses. Eighty-seven percent of intervention and 86% of control children attended every 6-mo visit ( P = 0.77). A total of 187 (34%) in the intervention group converted to caries active compared to 213 (39%) in the control group (odds ratio, 0.81; 95% confidence interval, 0.64-1.04; P = 0.11). Mean dmfs of those with caries in the intervention group was 7.2 compared to 9.6 in the control group ( P = 0.007). There was no significant difference in the number of episodes of pain between groups ( P = 0.81) or in the number of teeth extracted in caries-active children ( P = 0.95). Ten children in the intervention group had adverse reactions of a minor nature. This well-conducted trial failed to demonstrate that the intervention kept children caries free, but there was evidence that once children get caries, it slowed down its progression (EudraCT No: 2009-010725-39; ISRCTN: ISRCTN36180119).

Twenty years of the Cochrane Collaboration.

The Cochrane Collaboration is 20 years old this year. Established in 1993, the Collaboration has sought to provide an up-to-date, critical evidence base for all those involved in health care decision-making at a variety of levels. This article illustrates the work of the Cochrane Oral Health Group, based at the University of Manchester, UK.

A cluster-randomized controlled trial: fluoride varnish in school children.

We conducted a school-based parallel cluster randomized controlled trial with 36-month follow-up of children aged 7 to 8 years. Primary schools were randomly assigned to 2 groups: 3 applications of fluoride varnish (22,600 ppm) each year or no intervention. The primary outcome was DFS increment in the first permanent molars, with the hypothesis that 9 applications of varnish over 3 years would result in a lower increment in the test group. Follow-up measurements were recorded by examiners blind to the allocation. Ninety-five schools were randomized to the test and 95 to the reference groups; 1473 (test) and 1494 (reference) children participated in the trial. An intention-to-treat analysis was carried out with random effects models. The DFS increment was 0.65 (SD 2.15) in the test and 0.67 (SD 2.10) in the reference groups, respectively. There was no statistically significant difference between the groups. We were unable to demonstrate an effect for fluoride varnish when it was used as a public health intervention to prevent caries in the first permanent molar teeth (Inter-national Standard Randomized Controlled Trial Registration: ISRCTN: #72589426).

Cochrane reviews on the benefits/risks of fluoride toothpastes.

This concise review presents two Cochrane Reviews undertaken to determine: (1) the relative effectiveness of fluoride toothpastes of different concentrations in preventing dental caries in children and adolescents; and (2) the relationship between the use of topical fluorides in young children and their risk of developing dental fluorosis. To determine the relative effectiveness of fluoride toothpastes of different concentrations, we undertook a network meta-analysis utilizing both direct and indirect comparisons from randomized controlled trials (RCTs). The review examining fluorosis included evidence from experimental and observational studies. The findings of the reviews confirm the benefits of using fluoride toothpaste, when compared with placebo, in preventing caries in children and adolescents, but only significantly for fluoride concentrations of 1000 ppm and above. The relative caries-preventive effects of fluoride toothpastes of different concentrations increase with higher fluoride concentration. However, there is weak, unreliable evidence that starting the use of fluoride toothpaste in children under 12 months of age may be associated with an increased risk of fluorosis. The decision of what fluoride levels to use for children under 6 years should be balanced between the risk of developing dental caries and that of mild fluorosis.

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.

The development of evidence-based guidelines on mouth care for children, teenagers and young adults treated for cancer.

The aim was to produce evidence-based guidelines on mouth care for children, teenagers and young adults receiving chemotherapy and/or radiotherapy. Systematic reviews were undertaken and research was graded according to the methods of the Scottish Intercollegiate Guidelines Network. Where no relevant research was identified, an opinion-gathering process was undertaken. 'Best practice' recommendations were developed with regard to appropriate dental care and basic oral hygiene. An evaluation of oral assessment tools identified seven which had been assessed for reliability and/or validity. Only Eilers' Oral Assessment Guide was felt to be relevant for daily clinical practice. A variety of interventions have been used for the management of oral mucositis, candidiasis, xerostomia and herpes simplex virus; few are supported by research evidence. Careful oral management of children treated for cancer can improve the quality of life during treatment. The guidelines have the potential to improve patient care by promoting interventions of proven benefit and discouraging use of ineffective or potentially harmful practices which may result in adverse patient outcomes.

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/).

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 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.

Interventions for replacing missing teeth: different types of dental implants.

BACKGROUND: Dental implants are available in different materials, shapes and with different surface characteristics. In particular, numerous implant surface modifications have been developed for enhancing clinical performance. OBJECTIVES: To test the null hypothesis of no difference in clinical performance between various root-formed osseointegrated dental implant types. 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: All RCTs of oral implants comparing osseointegrated implants with different materials, shapes and surface properties having a follow up of at least 1 year. 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 (RR) for dichotomous outcomes with 95% confidence intervals (CI). MAIN RESULTS: Forty different RCTs were identified. Sixteen of these RCTs, reporting results from a total of 771 patients, were suitable for inclusion in the review. Eighteen different implant types were compared with a follow up ranging from 1 to 5 years. All implants were made in commercially pure titanium and had different shapes and surface preparations. On a 'per patient' rather than 'per implant' basis no significant differences were observed between various implant types for implant failures. There were statistically significant differences for perimplant bone level changes on intraoral radiographs in three comparisons in two trials. In one trial there was more bone loss only at 1 year for IMZ implants compared to Brånemark (mean difference 0.60 mm; 95% CI 0.01 to 1.10) and to ITI implants (mean difference 0.50 mm; 95% CI 0.01 to 0.99). In the other trial Southern implants displayed more bone loss at 5 years than Steri-Oss implants (mean difference -0.35 mm; 95% CI -0.70 to -0.01). However this difference disappeared in the meta-analysis. More implants with rough surfaces were affected by perimplantitis (RR 0.80; 95% CI 0.67 to 0.96) meaning that turned implant surfaces had a 20% reduction in risk of being affected by perimplantitis over a 3-year period. AUTHORS' CONCLUSIONS: Based on the available results of RCTs, there is limited evidence showing that implants with relatively smooth (turned) surfaces are less prone to lose bone due to chronic infection (perimplantitis) than implants with rougher surfaces. On the other hand, there is no evidence showing that any particular type of dental implant has superior long-term success. These findings are based on a few RCTs, often at high risk of bias, with few participants and relatively short follow-up periods. More RCTs should be conducted, with follow up of at least 5 years including a sufficient number of patients to detect a true difference. Such trials should be reported according to the CONSORT recommendations (http://www.consort-statement.org/).

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.

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. OBJECTIVES: The main objectives were: to determine the beneficial and harmful effects of routine scaling and polishing for periodontal health; to determine the beneficial and harmful effects of providing routine scaling and polishing at different time intervals on periodontal health; to compare the effects of routine scaling and polishing provided by a dentist or professionals complementary to dentistry (PCD) (dental therapists or dental hygienists) on periodontal health. 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 eligible studies were contacted where possible to identify 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 - anyone with an erupted permanent dentition who were judged to have received a 'routine scale and polish' (as defined in this review); interventions - 'routine scale and polish' (as defined in this review) and routine scale and polish provided at different time intervals; outcomes - tooth loss, plaque, calculus, gingivitis, bleeding and periodontal indices, changes in probing depth, attachment change, patient-centred outcomes and economic outcomes. 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 possible and where deemed necessary for further details regarding study design and for data clarification. A quality assessment of all included trials was carried out. The Cochrane Collaboration's statistical guidelines were followed and both standardised mean differences and mean differences were calculated as appropriate using random-effects models. MAIN RESULTS: Nine studies were included in this review. All studies were assessed as having a high risk of bias.Two split-mouth studies provided data for the comparison between scale and polish versus no scale and polish. One study, involving patients attending a recall programme following periodontal treatment, found no statistically significant differences for plaque, gingivitis and attachment loss between experimental and control units at each time point during the 1 year trial. The other study, involving adolescents in a developing country with high existing levels of calculus who had not received any dental treatment for at least 5 years, reported statistically significant differences in calculus and gingivitis (bleeding) scores between treatment and control units at 6, 12 and 22 months (in favour of 'scale and polish units') following a single scale and polish provided at baseline to treatment units. For comparisons between routine scale and polish provided at different time intervals, there were some statistically significant differences in favour of scaling and polishing provided at more frequent intervals: 2 weeks versus 6 months, 2 weeks versus 12 months (for the outcomes plaque, gingivitis, pocket depth and attachment change); 3 months versus 12 months (for the outcomes plaque, calculus and gingivitis). There were no studies comparing the effects of scaling and polishing provided by dentists or professionals complementary to dentistry. AUTHORS' CONCLUSIONS: The research evidence is of insufficient quality to reach any conclusions regarding the beneficial and adverse effects of routine scaling and polishing for periodontal health and regarding the effects of providing this intervention at different time intervals. High quality clinical trials are required to address the basic questions posed in this review.

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

BACKGROUND: Oral and oropharyngeal cancers can be managed by surgery alone or with any combination of radiotherapy, chemotherapy and immunotherapy/biotherapy. Opinions on the surgical treatment, the optimal combinational therapy and the sequence of treatments in combinational therapy varies enormously. OBJECTIVES: To determine which surgical treatment modalities for oral and oropharyngeal cancers lead to the best outcomes compared with other surgical, radiotherapy, chemotherapy or immunotherapy/biotherapy combinations. SEARCH STRATEGY: Electronic search of the Cochrane Oral Health Group Trials Register, CENTRAL, MEDLINE, OLDMEDLINE, EMBASE, AMED and the National Cancer Trials Database. Reference lists from relevant articles were searched and the authors of eligible trials were contacted. Date of the most recent searches: July 2007. SELECTION CRITERIA: Randomised controlled trials of surgery alone or in combination with chemotherapy, radiotherapy or immunotherapy/biotherapy for the treatment of primary oral or oropharyngeal cancer or both. DATA COLLECTION AND ANALYSIS: A minimum of two review authors conducted data extraction. Risk ratios were calculated for dichotomous outcomes at different time intervals, and hazard ratios were extracted or calculated for disease-free survival, total mortality, and disease-related mortality. Additional information from trial authors was sought. Data on adverse events were collected from the trial reports. MAIN RESULTS: Thirty-one trials satisfied the inclusion criteria, only 13 of which were assessed as low risk of bias. Trials were grouped into 12 main comparisons. There were no trials that compared different surgical modalities of the primary tumour itself. However, there were a number of trials comparing different approaches to managing the cervical lymph nodes. The majority of treatment regimens under evaluation were surgery in combination with other modalities. As individual treatment regimens within each comparison varied, meta-analysis was inappropriate in most instances. Only two trials could be pooled, comparing concomitant radio/chemotherapy (with surgery) versus radiotherapy (with surgery). A statistically significant difference was shown for disease-free survival (hazard ratio 0.77, 95% confidence interval (CI): 0.64 to 0.92) and total mortality (hazard ratio 0.78, 95% CI: 0.64 to 0.95) in favour of the concomitant chemotherapy and radiotherapy (with surgery) arm. No other treatment regimens showed consistent statistically significant results across the outcomes measured. AUTHORS' CONCLUSIONS: There is some evidence that concomitant radio/chemotherapy (with surgery) is more effective than radiotherapy (with surgery) and may benefit outcomes in patients with more advanced oral and oropharyngeal cancers. As these trials were based on head and neck studies, future studies should evaluate this treatment regimen specifically in oral and oropharyngeal cancers separately and also address tumour staging and its impact on outcomes. In general, future studies are encouraged to evaluate site-specific and stage-specific data for oral and oropharyngeal cancers. Future trials should include health-related quality of life assessment as an outcome measure. There is a need for a consolidated standardised approach to reporting adverse events.

Orthodontic treatment for prominent upper front teeth in children.

BACKGROUND: Prominent upper front teeth are an important and potentially harmful type of orthodontic problem. This condition develops when the child's permanent teeth erupt and children are often referred to an orthodontist for treatment with dental braces to reduce the prominence of the teeth. If a child is referred at a young age, the orthodontist is faced with the dilemma of whether to treat the patient early or to wait until the child is older and provide treatment in early adolescence. When treatment is provided during adolescence the orthodontist may provide treatment with various orthodontic braces, but there is currently little evidence of the relative effectiveness of the different braces that can be used. OBJECTIVES: To assess the effectiveness of orthodontic treatment for prominent upper front teeth, when this treatment is provided when the child is 7 to 9 years old or when they are in early adolescence or with different dental braces or both. SEARCH STRATEGY: The Cochrane Oral Health Group's Trials Register, CENTRAL, MEDLINE and EMBASE were searched. The handsearching of the key international orthodontic journals was updated to December 2006. There were no restrictions in respect to language or status of publication. Date of most recent searches: February 2007. SELECTION CRITERIA: Trials were selected if they met the following criteria: design - randomised and controlled clinical trials; participants - children or adolescents (age < 16 years) or both receiving orthodontic treatment to correct prominent upper front teeth; interventions - active: any orthodontic brace or head-brace, control: no or delayed treatment or another active intervention; primary outcomes - prominence of the upper front teeth, relationship between upper and lower jaws; secondary outcomes: self esteem, any injury to the upper front teeth, jaw joint problems, patient satisfaction, number of attendances required to complete treatment. DATA COLLECTION AND ANALYSIS: Information regarding methods, participants, interventions, outcome measures and results were extracted independently and in duplicate by two review authors. The Cochrane Oral Health Group's statistical guidelines were followed and mean differences were calculated using random-effects models. Potential sources of heterogeneity were examined. MAIN RESULTS: The search strategy identified 185 titles and abstracts. From this we obtained 105 full reports for the review. Eight trials, based on data from 592 patients who presented with Class II Division 1 malocclusion, were included in the review.Early treatment comparisons: Three trials, involving 432 participants, compared early treatment with a functional appliance with no treatment. There was a significant difference in final overjet of the treatment group compared with the control group of -4.04 mm (95% CI -7.47 to -0.6, chi squared 117.02, 2 df, P < 0.00001, I(2) = 98.3%). There was a significant difference in ANB (-1.35 mm; 95% CI -2.57 to -0.14, chi squared 9.17, 2 df, P = 0.01, I(2) = 78.2%) and change in ANB (-0.55; 95% CI -0.92 to -0.18, chi squared 5.71, 1 df, P = 0.06, I(2) = 65.0%) between the treatment and control groups. The comparison of the effect of treatment with headgear versus untreated control revealed that there was a small but significant effect of headgear treatment on overjet of -1.07 (95% CI -1.63 to -0.51, chi squared 0.05, 1 df, P = 0.82, I(2) = 0%). Similarly, headgear resulted in a significant reduction in final ANB of -0.72 (95% CI -1.18 to -0.27, chi squared 0.34, 1 df, P = 0.56, I(2) = 0%). No significant differences, with respect to final overjet, ANB, or ANB change, were found between the effects of early treatment with headgear and the functional appliances. Adolescent treatment (Phase II): At the end of all treatment we found that there were no significant differences in overjet, final ANB or PAR score between the children who had a course of early treatment, with headgear or a functional appliance, and those who had not received early treatment. Similarly, there were no significant differences in overjet, final ANB or PAR score between children who had received a course of early treatment with headgear or a functional appliance. One trial found a significant reduction in overjet (-5.22 mm; 95% CI -6.51 to -3.93) and ANB (-2.27 degrees; 95% CI -3.22 to -1.31, chi squared 1.9, 1 df, P = 0.17, I(2) = 47.3%) for adolescents receiving one-phase treatment with a functional appliance versus an untreated control.A statistically significant reduction of ANB (-0.68 degrees; 95% CI -1.32 to -0.04, chi squared 0.56, 1 df, P = 0.46, I(2) = 0%) with the Twin Block appliance when compared to other functional appliances. However, there was no significant effect of the type of appliance on the final overjet. AUTHORS' CONCLUSIONS: The evidence suggests that providing early orthodontic treatment for children with prominent upper front teeth is no more effective than providing one course of orthodontic treatment when the child is in early adolescence.

Paracetamol for pain relief after surgical removal of lower wisdom teeth.

BACKGROUND: Paracetamol has been commonly used for the relief of postoperative pain following oral surgery. In this review we investigated the optimal dose of paracetamol and the optimal time for drug administration to provide pain relief, taking into account the side effects of different doses of the drug. This will inform dentists and their patients of the best strategy for pain relief after the surgical removal of wisdom teeth. OBJECTIVES: To assess the beneficial and harmful effects of paracetamol for pain relief after surgical removal of lower wisdom teeth, compared to placebo, at different doses and administered postoperatively. SEARCH STRATEGY: We searched the Cochrane Oral Health Group's Trials Register; the Cochrane Pain, Palliative and Supportive Care Group's Trials Register; CENTRAL; MEDLINE; EMBASE and the Current Controlled Trials Register. 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 manufacturers of analgesic pharmaceuticals, we searched personal references in an attempt to identify unpublished or ongoing RCTs. No language restriction was applied. The last electronic search was conducted on 24th August 2006. SELECTION CRITERIA: Randomised, parallel group, placebo controlled, double blind clinical trials of paracetamol for acute pain, following third molar surgery. DATA COLLECTION AND ANALYSIS: All trials identified were scanned independently and in duplicate by two review authors, any disagreements were resolved by discussion, or if necessary a third review author was consulted. The proportion of patients with at least 50% pain relief was calculated for both paracetamol and placebo. The number of patients experiencing adverse events, and/or the total number of adverse events reported were analysed. MAIN RESULTS: Twenty-one trials met the inclusion criteria. A total of 2048 patients were initially enrolled in the trials (1148 received paracetamol, and 892 the placebo) and of these 1968 (96%) were included in the meta-analysis (1133 received paracetamol, and 835 the placebo). Paracetamol provided a statistically significant benefit when compared with placebo for pain relief and pain intensity at both 4 and 6 hours. Most studies were found to have moderate risk of bias, with poorly reported allocation concealment being the main problem. Risk ratio values for pain relief at 4 hours 2.85 (95% confidence interval (CI) 1.89 to 4.29), and at 6 hours 3.32 (95% CI 1.88 to 5.87). A statistically significant benefit was also found between up to 1000 mg and 1000 mg doses, the higher the dose giving greater benefit for each measure at both time points. There was no statistically significant difference between the number of patients who reported adverse events, overall this being 19% in the paracetamol group and 16% in the placebo group. AUTHORS' CONCLUSIONS: Paracetamol is a safe, effective drug for the treatment of postoperative pain following the surgical removal of lower wisdom teeth.