Abstract
BACKGROUND: The use of orthodontic fixed appliances is strongly linked to enamel demineralization. Numerous solutions have been presented; however, the best one remains controversial. OBJECTIVES: To evaluate the effect of Biosmalto Impact Action Mousse™ (biomimetic materials) on white spot lesions (WSLs) development during orthodontic treatment. TRIAL DESIGN: Multicenter, parallel groups, randomized clinical trial. METHODS: A computer random number generator allocated 70 orthodontic patients aged 12 or older to two groups. The control group used Colgate toothpaste daily, whereas the intervention group used Curasept toothpaste daily with the application of Curasept Biosmalto Impact Action Mousse™ to the anterior teeth every visit. The individuals were assessed monthly for six months. Enamel mineralization, visible plaque index (VPI), and gingival bleeding index (GBI) were measured on the upper and lower anterior teeth. Each tooth was assessed for enamel mineralization using the DIAGNOdent Pen, International Caries Detection and Assessment System (ICDAS), and Gorelick index (GOI). RESULTS: The analysis included 62 participants (30 Colgate and 32 Curasept). Both groups had comparable DIAGNOdent pen scores at all time intervals. There was a statistically significant higher DIAGNOdent pen scores over time in both groups. No statistically significant differences were found between groups for ICDAS and GOI. The Colgate group had statistically significantly higher VPI scores at T2 (after 8 weeks), T4 (after 16 weeks), T5 (after 20 weeks), and T6 (after 24 weeks) and GBI scores at T4, T5, and T6. LIMITATIONS: The study findings only demonstrated the effect of biomimetic materials during six months of orthodontic treatment. Long-term effect is worth to be also evaluated. CONCLUSIONS: Monthly application of Biosmalto Impact Action Mousse™ did not seem to be more effective than fluoridated toothpaste on the development of WSLs after six months. REGISTRATION: The study was registered with ClinicalTrials.gov on July 11, 2023 (Registration No. NCT05940701).