Self-assembling peptide and nano-silver fluoride in remineralizing early enamel carious lesions: randomized controlled clinical trial

BACKGROUND: Nanoparticles and regenerative biomineralization are new caries prevention technologies. This study assessed the remineralizing effect of self-assembling peptide (P11-4), Nanosilver Fluoride (NSF) and sodium fluoride (NaF) on white spot lesions (WSLs) in permanent teeth. METHODS: Sixty six young adults with WSLs on buccal surfaces in permanent teeth and ICDAS code 1 or 2, were randomly assigned to one of three groups; P11-4, NSF or NaF. Assessment of ICDAS scores, lesion activity (Nyvad scores) and diagnodent readings of lesions were done at baseline and after 1, 3, 6 and 12 months of agents’ application. Comparisons between groups were made using chi squared test and comparison within groups were made using McNemar test. Multilevel binary logistic regression was used to assess the effect of agents on change of ICDAS scores after 3, 6 and 12 months (reduction versus no reduction). RESULTS: There were 147 teeth in 66 patients; mean ± SD age = 13.46 ± 4.31 years. There were significant differences in the change of ICDAS scores among the three groups after 3 and 6 months (p = 0.005). The reduction in ICDAS score increased steadily in all groups across time with the greatest increase in the P11-4 group: 54.5% after 12 months. Lesion activity (Nyvad scores) showed significant differences among the three groups with the greatest percentage of inactive cases in the P11-4 group. Multilevel binary logistic regression showed non-significant reduction of ICDAS in P11-4 and NSF varnishes compared to NaF varnish (AOR = 2.56, 95% CI: 0.58, 8.77 and AOR = 2.12, 95% CI: 0.59, 7.64 respectively). CONCLUSION: P11-4 and NSF varnish reduced the ICDAS scores, caries activity and diagnodent readings of WSLs in permanent teeth. However, the change in ICDAS scores was not significantly different from NaF. TRIAL REGISTRATION: This trial was prospectively registered on the clinicaltrials.gov registry with ID: NCT04929509 on 18/6/2021.