A prospective, randomized placebo-controlled clinical trial on the effects of a fluoride rinse on white spot lesion development and bleeding in orthodontic patients

Abstract

Demineralizations around orthodontic brackets are a main disadvantage of orthodontic treatment. Several methods have been advocated to prevent their development, such as fluoride rinses or varnishes. In this randomized clinical trial, a fluoride rinse (a combination of sodium fluoride and amine fluoride) was compared with a placebo rinse, to be used every evening after toothbrushing. A total of 81 participants (mean age: 13.3 yr) completed the study (mean treatment period: 24.5 months). Demineralizations, measured using quantitative light-induced fluorescence and the decayed, missing, and filled surfaces (DMFS) index, were assessed before treatment (baseline) and around 6 wk after debonding (post treatment). Bleeding scores were measured at baseline, and during and post treatment. The incidence rate ratio for demineralizations was 2.6 (95% CI: 1.1-6.3) in the placebo group vs. the fluoride group. In the fluoride group, 31% of participants developed at least one demineralization, compared with 47% in the placebo group. Relative to baseline, gingival bleeding increased significantly in the placebo group 1 yr after the start of treatment and onwards. For the fluoride group, bleeding scores during treatment were not different from those at baseline. In conclusion, using a fluoride rinse helps to maintain better oral health during fixed appliance treatment, resulting in fewer demineralizations.

Keywords: caries prevention; fixed orthodontic appliances; fluoride rinse; gingival bleeding; tooth demineralization.

Figure 1

Flow‐chart showing the different study time points and corresponding assessments. The caries assessments made at TD1 were used for the analyses. ICDAS, International Caries Detection and Assessment System; DMFS, decayed, missing, and filled surfaces; QLF, quantitative light‐induced fluorescence.

Figure 2

Flow‐chart showing the participant follow up during the study and the number of participants available for each analysis. Treatment periods with appliances: T0, prebracketing; T1, 6 wk post bracketing; T2, 12 wk post bracketing; T3, 6 months post bracketing; T4, 12 months post bracketing; T5, 18 months post bracketing; and T6, 24 months post bracketing. Caries assessment time points: TD, immediately post bracketing; TD1, 6 wk post bracketing; and TD2, 12 wk post bracketing. WSL, white spot lesion.

Figure 3

Percentage of total participants and their white spot lesion counts, 52 d after debonding. In the fluoride group, 69.4% of the participants were WSL‐free, compared with 53.3% in the placebo group after treatment with fixed orthodontic appliances.

Figure 4

Bleeding scores during visit T0 (prebracketing) and visits T1–T6 (6, 12 wk, 6, 12, 18, and 24 months post bracketing), for the fluoride (left panel) and placebo rinse (right panel). At visit T4 and at subsequent visits the placebo group differs significant compared to baseline. The fluoride group did not show a difference.