A COnsensus-based Standards for the selection of health Measurement INstruments systematic review of orthognathic patient-reported outcome measures.

INTRODUCTION: This systematic review aimed to identify and appraise the validity studies of patient-reported outcome measures (PROMs) reporting the outcomes of combined orthodontic-orthognathic surgery in treating dentofacial deformity. METHODS: The search strategy was conducted using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Systematic Review methodology. The following databases were searched for original studies outlining the development and/or validation of PROMs produced to measure the outcomes of combined orthognathic-orthodontic treatment: EMBASE, MEDLINE, PsycInfo and Scopus. Publications were limited to the English language. Eligibility criteria were applied when considering the studies. Primarily, the psychometric properties and quality of orthognathic-specific PROMs were investigated. Screening of eligible studies was conducted independently by 2 reviewers. Assessment of the methodological quality of the studies and data extraction was conducted by 1 reviewer and assisted by a second reviewer. The COSMIN methodology guided data extraction and analysis, which were divided into 3 stages-a synopsis of studies, evaluation of methodological quality, and summary of evidence. RESULTS: A total of 8695 papers were found; 12 studies met the criteria for inclusion. Regarding the COSMIN Checklist for Assessing Study Qualities, there was evidence that the Orthognathic Quality of Life Questionnaire was the most extensively tested orthognathic-specific PROM in the current literature. The reported evidence was incomplete, as not all psychometric properties had been reliably tested. CONCLUSIONS: Clinicians must use validated PROMs when analyzing patient-reported outcomes. The Orthognathic Quality of Life Questionnaire was shown to be the highest quality orthognathic-specific PROM in the literature but requires contemporary evaluation to suitably reflect the COSMIN guidance.

Fluorides for preventing early tooth decay (demineralised lesions) during fixed brace treatment.

BACKGROUND: Early dental decay or demineralised lesions (DLs, also known as white spot lesions) can appear on teeth during fixed orthodontic (brace) treatment. Fluoride reduces decay in susceptible individuals, including orthodontic patients. This review compared various forms of topical fluoride to prevent the development of DLs during orthodontic treatment. This is the second update of the Cochrane Review first published in 2004 and previously updated in 2013. OBJECTIVES: The primary objective was to evaluate whether topical fluoride reduces the proportion of orthodontic patients with new DLs after fixed appliances. The secondary objectives were to examine the effectiveness of different modes of topical fluoride delivery in reducing the proportions of orthodontic patients with new DLs, as well as the severity of lesions, in terms of number, size and colour. Participant-assessed outcomes, such as perception of DLs, and oral health-related quality of life data were to be included, as would reports of adverse effects. SEARCH METHODS: Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 1 February 2019), the Cochrane Central Register of Controlled Trials (CENTRAL; 2019, Issue 1) in the Cochrane Library (searched 1 February 2019), MEDLINE Ovid (1946 to 1 February 2019), and Embase Ovid (1980 to 1 February 2019). The US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for ongoing trials. No restrictions were placed on the language or date of publication when searching the electronic databases. SELECTION CRITERIA: Parallel-group, randomised controlled trials comparing the use of a fluoride-containing product versus a placebo, no treatment or a different type of fluoride treatment, in which the outcome of enamel demineralisation was assessed at the start and at the end of orthodontic treatment. DATA COLLECTION AND ANALYSIS: At least two review authors independently, in duplicate, conducted risk of bias assessments and extracted data. Authors of trials were contacted to obtain missing data or to ask for clarification of aspects of trial methodology. Cochrane's statistical guidelines were followed. MAIN RESULTS: This update includes 10 studies and contains data from nine studies, comparing eight interventions, involving 1798 randomised participants (1580 analysed). One report contained insufficient information and the authors have been contacted. We assessed two studies as at low risk of bias, six at unclear risk of bias, and two at high risk of bias. Two placebo (non-fluoride) controlled studies, at low risk of bias, investigated the professional application of varnish (7700 or 10,000 parts per million (ppm) fluoride (F)), every six weeks and found insufficient evidence of a difference regarding its effectiveness in preventing new DLs (risk ratio (RR) 0.52, 95% confidence interval (CI) 0.14 to 1.93; 405 participants; low-certainty evidence). One placebo (non-fluoride) controlled study, at unclear risk of bias, provides a low level of certainty that fluoride foam (12,300 ppm F), professionally applied every two months, may reduce the incidence of new DLs (12% versus 49%) after fixed orthodontic treatment (RR 0.26, 95% CI 0.11 to 0.57; 95 participants). One study, at unclear risk of bias, also provides a low level of certainty that use of a high-concentration fluoride toothpaste (5000 ppm F) by patients may reduce the incidence of new DLs (18% versus 27%) compared with a conventional fluoride toothpaste (1450 ppm F) (RR 0.68, 95% CI 0.46 to 1.00; 380 participants). There was no evidence for a difference in the proportions of orthodontic patients with new DLs on the teeth after treatment with fixed orthodontic appliances for the following comparisons: - an amine fluoride and stannous fluoride toothpaste/mouthrinse combination versus a sodium fluoride toothpaste/mouthrinse, - an amine fluoride gel versus a non-fluoride placebo applied by participants at home once a week and by professional application every three months, - resin-modified glass ionomer cement versus light-cured composite resin for bonding orthodontic brackets, - a 250 ppm F mouthrinse versus 0 ppm F placebo mouthrinse, - the use of an intraoral fluoride-releasing glass bead device attached to the brace versus a daily fluoride mouthrinse. The last two comparisons involved studies that were assessed at high risk of bias, because a substantial number of participants were lost to follow-up. Unfortunately, although the internal validity and hence the quality of the studies has improved since the first version of the review, they have compared different interventions; therefore, the findings are only considered to provide low level of certainty, because none has been replicated by follow-up studies, in different settings, to confirm external validity. A patient-reported outcome, such as concern about the aesthetics of any DLs, was still not included as an outcome in any study. Reports of adverse effects from topical fluoride applications were rare and unlikely to be significant. One study involving fluoride-containing glass beads reported numerous breakages. AUTHORS' CONCLUSIONS: This review found a low level of certainty that 12,300 ppm F foam applied by a professional every 6 to 8 weeks throughout fixed orthodontic treatment, might be effective in reducing the proportion of orthodontic patients with new DLs. In addition, there is a low level of certainty that the patient use of a high fluoride toothpaste (5000 ppm F) throughout orthodontic treatment, might be more effective than a conventional fluoride toothpaste. These two comparisons were based on single studies. There was insufficient evidence of a difference regarding the professional application of fluoride varnish (7700 or 10,000 ppm F). Further adequately powered, randomised controlled trials are required to increase the certainty of these findings and to determine the best means of preventing DLs in patients undergoing fixed orthodontic treatment. The most accurate means of assessing adherence with the use of fluoride products by patients and any possible adverse effects also need to be considered. Future studies should follow up participants beyond the end of orthodontic treatment to determine the effect of DLs on patient satisfaction with treatment.

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

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

Periodontal health of palatally displaced canines treated with open or closed surgical technique: a multicenter, randomized controlled trial.

INTRODUCTION: The aim of this study was to investigate differences in the periodontal outcomes of palatally displaced canines (PDC) exposed with either an open or a closed surgical technique. METHODS: A multicenter, randomized controlled trial was undertaken in 3 hospitals in the United Kingdom, involving 2 parallel groups. Patients with unilateral PDC were randomly allocated to receive either an open or a closed surgical exposure. Periodontal health was assessed 3 months after removal of fixed appliances. Parameters measured included clinical attachment levels, recession, alveolar bone levels, and clinical crown height. RESULTS: Data from 62 participants (closed, 29; open, 33) were analyzed. There was no difference between PDC exposed with an open vs a closed surgical technique (mean difference, 0.1 mm; 95% confidence interval [CI], -0.2-0.5). There was, however, a statistical difference in mean attachment loss between the operated and unoperated (contralateral) canines (mean difference, 0.5 mm; 96% CI, 0.4-0.7; P <0.001). Twenty of the 62 subjects had some recession on the palatal aspect of the operated canine, whereas only 4 subjects had some visible root surface on the palatal aspect on the unoperated side (P = 0.001). CONCLUSIONS: There is a periodontal impact when a unilateral PDC is exposed and aligned. This impact is small and unlikely to have clinical relevance in the short term; however, the long-term significance is unknown. When the open and closed techniques were compared, no difference in periodontal health was found.