Effectiveness of Self-assembling Peptide (P11-4) in Conjunction With Fluoride Varnish in the Management of White Spot Lesions in Primary Teeth (Randomized Controlled Clinical Trial)

Abstract

Abstract Background Sodium fluoride (NaF) varnish is considered the gold standard for the treatment of white spot lesions (WSLs) in primary teeth. Biomimetic regeneration using Self-Assembling Peptide P11-4 (SAP) is an alternative approach for minimal invasive treatment of initial carious lesions. This study aimed to clinically assess the effect of P11-4 in conjunction with 5% NaF varnish versus 5% NaF varnish alone, on remineralization of WSLs in primary teeth. Methods Twenty-four children, aged 3 to 6 years with visible active WSLs (ICDAS II score 1–3) on primary teeth were randomly allocated into 2 equal groups. The test group was treated with Curodont™ Repair [(SAP (P11-4)] and Duraflor varnish (5%NaF), while the control group was treated with Duraflor varnish alone. Before treatment, baseline assessments were done using ICDAS II scores, Nyvad criteria for lesion activity and DIAGNOdent ™ measurements. After that the materials in both groups were applied according to the manufacture’s instructions. Patients were recalled after 3 and 6 months for lesion assessment and re-application of 5%NaF. Groups were statistically compared using Mann Whitney and Chi-square tests. Changes across time were assessed within each group using Friedman test followed by post hoc test. Results Intergroup comparison showed a decrease in the DIAGNOdent ™ readings with no significant difference at the 3 and 6 months follow up (P = 0.297 and 0.183 respectively). The study group showed a significant difference in the DIAGNOdent ™ readings between baseline and 6 months follow up (P = 0.009) while the control group showed no significant difference (P = 0.085). At 6 months follow up, in the study group (75%) of the WSL became inactive and in the control group (50%) became inactive with no significant difference between the 2 groups (P = 0.400). Regarding the ICDAS II scores no significant change was observed throughout the different time intervals where P = 0.368 and 0.368 respectively. Conclusions Self-Assembling Peptide in conjunction with 5% NaF varnish showed superior remineralization of WSLs compared to 5% NaF varnish only after 6 months follow up. Trial registration: the clinical trial was registered in ClinicalTrials.gov under the number NCT05721586 (10/02/2023)