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Objectives: Objective of this trial was to assess the masking results in initial caries lesions (ICL) that were resin infiltrated during fixed orthodontic treatment in comparison to contralateral teeth that were fluoridated only.

Trial design: A randomized, controlled, split-mouth trial.

Methods: Adolescent patients (age range: 12-18 years) with fixed orthodontic appliances who had developed ICL [ICDAS 1 or 2 (International Caries Detection and Assessment System)] during orthodontic treatment were consecutively recruited and randomly assigned to either resin infiltration (Icon) with up to 3 etching procedures (Inf) or to a fluoride varnish (Tiefenfluorid) (FV). Both interventions were performed according to the manufacturer's recommendations. Outcome assessors were blinded to the applied intervention. Primary and secondary outcomes included the evaluation of the appearance of the ICL before (T0) and 1 week after (T1) treatment by digital photographs (ΔE), laser fluorescence readings (DD), and ICDAS scores.

Blinding: Due to the treatment nature neither the operators nor the patients could be blinded. However, outcome assessors and the statistician were blinded.

Results: Fifteen patients (9 female) with 60 ICL were included (mean age: 14.6 years). At baseline FV and Inf did not differ significantly in ΔE (median ΔE0,T (25th/75th percentiles):10.7(9.1/20.9): ΔE0,I:13.4(10.3/18.5); P = 0.469), DD (P = 0.867) and ICDAS (P = 0.521). One-week after treatment (T1) ΔE values (P < 0.001), DD values (P < 0.001), and ICDAS scores (P = 0.014) for Inf were significantly reduced, whereas ΔE values (P = 0.125) and ICDAS scores (P = 0.073) for FV remained unchanged.

Limitation: Natural remineralizing in the standard interventional control group cannot be observed yet, since up to 6 months are needed to naturally remineralize ICL.

Conclusions: Based on our short-term data, resin infiltration effectively masked ICL during treatment with fixed orthodontic appliances. Fluoridation was not able to immediately improve the visual appearance of ICL. Further longer-term assessment should focus not only on the aesthetic outcome, but also on the caries inhibitory effect of resin infiltration during treatment with fixed orthodontic appliances.

Trial registration: German Clinical Trials Register (DRKS-ID: DRKS00011797).