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Meta-Analysis
. 2019 Nov 17;2019(11):CD003809.
doi: 10.1002/14651858.CD003809.pub4.

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

Affiliations
Meta-Analysis

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

Philip E Benson et al. Cochrane Database Syst Rev. .

Abstract

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.

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Conflict of interest statement

Three of the review authors (Philip Benson, Declan Millett and Fiona Dyer) were authors for one of the included studies (Benson 2019). The evaluation of this study, including data extraction and methodological quality assessments, was reviewed and confirmed by two authors not involved in this study (Nicola Parkin and Peter Germain).

Figures

1
1
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
2
2
Study flow diagram.
1.1
1.1. Analysis
Comparison 1 Professionally‐applied F varnish versus non‐F (placebo) varnish, Outcome 1 Number of participants with new DLs.
1.2
1.2. Analysis
Comparison 1 Professionally‐applied F varnish versus non‐F (placebo) varnish, Outcome 2 Number of participants with more severe DLs (scores 3 or 4 versus scores 1 or 2).
2.1
2.1. Analysis
Comparison 2 12,500 ppm F (NaF/olaflur/dectaflur) gel versus 0 ppm F placebo gel, Outcome 1 Number of participants with new DLs.
3.1
3.1. Analysis
Comparison 3 12,300 ppm F APF foam versus 0 ppm F placebo foam, Outcome 1 Number of participants with new DLs.
4.1
4.1. Analysis
Comparison 4 5000 ppm F toothpaste versus 1450 ppm F toothpaste, Outcome 1 Number of participants with new DLs.
5.1
5.1. Analysis
Comparison 5 250 ppm F mouthrinse (100 ppm AmF/150 ppm NaF) versus 0 ppm F placebo mouthrinse, Outcome 1 Number of participants with new DLs.
6.1
6.1. Analysis
Comparison 6 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations, Outcome 1 White spot index.
6.2
6.2. Analysis
Comparison 6 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations, Outcome 2 Visible plaque index.
6.3
6.3. Analysis
Comparison 6 1400 ppm/250 ppm F (AmF/SnF) versus 1400 ppm/250 ppm F (NaF) toothpaste/mouthrinse combinations, Outcome 3 Gingival bleeding index.
7.1
7.1. Analysis
Comparison 7 Resin‐modified glass ionomer cement (RM‐GIC) versus light‐cured composite resin (LCC), Outcome 1 Number of participants with new DLs.
7.2
7.2. Analysis
Comparison 7 Resin‐modified glass ionomer cement (RM‐GIC) versus light‐cured composite resin (LCC), Outcome 2 Number of participants with more severe DLs of aesthetic concern.
8.1
8.1. Analysis
Comparison 8 Intraoral F‐releasing glass bead device versus F mouthrinse only, Outcome 1 Number of participants with new DLs.

Update of

Comment in

References

References to studies included in this review

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References to ongoing studies

DRKS00012533 {published and unpublished data}
    1. DRKS00012533. Efficacy of the fluoride varnish enamelast for preventing white‐spot lesions and gingivitis in fixed orthodontic treatment of patients with low to moderate caries risk ‐ a randomized controlled trial. drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00... (first received 8 June 2017).
DRKS00012540 {published and unpublished data}
    1. DRKS00012540. Efficacy of Fluor‐Protector S fluoride varnish for preventing white‐spot lesions and gingivitis in fixed orthodontic treatment of patients with high risk of caries ‐ a randomized controlled trial. drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00... (first received 8 June 2017).
IRCT2016122531558N1 {published and unpublished data}
    1. IRCT2016122531558N1. Effect of preventive agents on oral health in orthodontic patients [A clinical trial of comparing the effect of fluoride varnish and chlorhexidine gel on white spots and gingival indexes in orthodontic patients]. en.irct.ir/trial/24800 (first received 24 June 2017).

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References to other published versions of this review

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