Evaluation of the preventive effect of two concentrations of xylitol varnish versus fluoride varnish on enamel demineralization around orthodontic brackets: a randomized controlled trial.

Background: The highly prevalent white spot lesions around orthodontic brackets necessitate introducing preventive materials without relying on patient compliance.

Objective: To evaluate the antidemineralizing effect of two concentrations of xylitol varnish.

Trial Design: Triple-blind, four-arm, parallel-group, single-center, randomized controlled clinical trial.

Methods: A total of 120 orthodontic patients were randomly assigned to four groups (n = 30), using a computer-generated randomized block list. The treatment groups were: 10% xylitol, 20% xylitol, 5% fluoride, and placebo. Tooth demineralization was measured with DIAGNOdent at T1 (before treatment), followed by varnish application. At T2 (third month), the varnish was re-applied, and at the third (T2) and sixth (T3) months, and after treatment (T4), the demineralization was measured. The white spot lesion frequency was assessed visually after treatment. The participants, the clinician, and data assessors were all blinded to group assignments.

Results: A total of 115 patients underwent per-protocol analyses. At T2, the mean DIAGNOdent numbers in the fluoride and 10% xylitol groups were significantly lower than the placebo group (P = 0.00), with a mean difference of 0.63 (95% CI, 0.15-1.10) and 0.5 (95% CI, 0.04-0.95), respectively. At T3, the fluoride and 10% xylitol groups had significantly lower mineral loss than the placebo group (P=0.046) with a mean difference of 0.52 (95% CI, 0.14-0.89) in the fluoride and 0.45 (95% CI, 0.03-0.86) in the 10% xylitol groups, respectively. However, at T4, only the mean for the 10% xylitol group was significantly different (P=0.049) from the placebo group, with a mean difference of 1.18 (95% CI, 0.42-1.93). Visual assessment showed that after treatment, the prevalence of white spot lesions in the fluoride (P=0.03) and 10% xylitol (P=0.00) groups was less than the placebo group with the odds ratio of 0.67 (95% CI, 0.46-0.96) and 0.43 (95% CI, 0.28-0.64), respectively.

Conclusion: The 10% xylitol varnish short-term effects on caries control were significantly greater than 20% xylitol varnish and placebo but similar to fluoride varnish. However, the 10% xylitol long-term effect was almost better than fluoride varnish.

Trial Registration: The protocol was registered at IRCT.ir under the code IRCT20180913041032N1.