A prospective, triple-blind, randomized controlled clinical trial evaluating the protective effect of P11-4 peptide on enamel demineralization during multibracket orthodontic treatment

This prospective, triple-blind, randomized controlled clinical trial evaluated the additional caries-preventive effect of a self-assembling peptide (P11-4) gel with fluoride applied at home during multibracket (MB) orthodontic treatment in adolescents. Twenty-five patients aged 11–17 years (mean age 14.5 years) were randomized to a test group (P11-4 gel including 900 ppm sodium monofluorophosphate) or a placebo group (900 ppm sodium monofluorophosphate gel without P11-4 gel). Participants applied the assigned gel twice weekly for 18 months. Caries development was assessed using the International Caries Detection and Assessment System (ICDAS) and quantitative light-induced fluorescence (QLF) at baseline (t0), and after 6 (t1), 12 (t2), and 18 months (t3) after baseline. Statistical analyses were performed using non-parametric tests (α = 0.05). At 18 months, 7.2% of surfaces in the test group and 14.5% in the placebo group showed initial lesions (ICDAS 1 or 2; p < 0.0001). All QLF parameters showed significantly lower demineralization in the test group throughout the study (p < 0.0001). In the test group, QLF parameters at t3 were: ΔF = -0.91%, ΔFmax = -1.17% and ΔQ = -12.06%px. Corresponding values in the placebo group were: ΔF = -2.07%, ΔFmax = -2.75% and ΔQ = -36.31%px. Lesion volume (ΔQ) decreased over time in the test group, indicating remineralization. No adverse effects were observed. Regular home use of P11-4 gel with fluoride reduced the development of enamel demineralization in adolescents with fixed appliances. Despite the small sample size and limited patient-level power, the findings indicate that P11-4 with fluoride can serve as a useful adjunct to established home-based preventive measures during orthodontic treatment. A biomimetic peptide gel with fluoride used at home can prevent development of initial caries lesions during orthodontic treatment and may benefit patients with limited oral hygiene or high caries risk. The study was conducted in accordance with the World Medical Association Declaration of Helsinki. The study protocol was reviewed and approved by the Ethics Committee of the Medical Faculty of the Philipps-University of Marburg, Germany (approval number 197/21, date of approval: 20 January 2022). The study protocol was registered in the German Clinical Trials Register: Trial registration number: DRKS00028048, date of registry: 07 February 2022). The study was conducted following the Good Clinical Practice standards and the General Data Protection Regulation (GDPR).