Evaluation of the remineralizing effect of biomimetic self-assembling peptides in post-orthodontic white spot lesions compared to fluoride-based delivery systems: randomized controlled trial.

OBJECTIVES: To evaluate the clinical performance of self-assembling peptides versus fluoride-based delivery systems in post-orthodontic white spot lesions. MATERIALS AND METHODS: The participants were randomly assigned into two groups (n = 58) according to the remineralizing agent used, where (A) group represented participants receiving a varnish containing 22.600 fluoride ppm and tricalcium phosphate, while the second group (B) represented participants receiving self-assembling peptide. The remineralizing process of the white spot lesion was assessed using the DIAGNOdent pen and ICDAS scoring system according to the time when the remineralizing agent was used (T), where T0 represented the score taken at baseline. T1 represented the score taken after 3 months of follow-ups and T2 score represented the score taken after 6 months of follow-up. Data were collected and statistically analyzed. The parametric data: two-way ANOVA was used to test the effect of interaction among different variables. The non-parametric data: Mann-Whitney test was used. The significance level was set at p ≤ 0.05. RESULTS: There was a quantitative statistically significant difference via DIAGNOpen readings between Group A (fluoride material) and Group B (self-assembling peptides). The highest mean value of 10.51 was found in Group A, while the least mean value of 6.45 was found in Group B. Besides, there was a significant difference in each group concerning the time factors T0, T1, and T2 groups where (p < 0.001. As for the qualitative results concerning the ICDAS score, there was no significant difference between the two groups along with the follow-up periods T0, T1, and T2 where the p value is equal to 0.064, 0.087, and 0.277 respectively. CONCLUSIONS: The visual assessment using ICDAS reveals that the biomimetic remineralization using self-assembling peptides and the fluoride-based varnish material showed a similar effect in masking post-orthodontic white spot lesions. However, the laser fluorescence using DIAGNOpen showed that the self-assembling peptides reveal higher performance in subsurface remineralization than the fluoride-based varnish material. Therefore, self-assembling peptides are considered a promising material for lesion regression in post-orthodontics white spot lesions. CLINICAL RELEVANCE: Self-assembling peptide SAP-14 is a new approach to reverse and mask off post-orthodontics white spot lesions.