Self-assembling peptide and nano-silver fluoride in remineralizing early enamel carious lesions: Randomized Controlled Clinical Trial

Abstract

Abstract 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 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 X2 test and comparison within groups were made using McNemar test. Multilevel logistic regression analysis was used to assess the effect of agents on change of ICDAS scores after 12 months. Results There were 147 teeth in 66 patients; mean ± SD age = 13.46 ± 4.31 years. There was significant difference in change of ICDAS scores among the three groups after 3 and 6 months (p = 0.005). The regression in ICDAS score increased in all groups in all follow-up intervals with the greatest was among P11-4 group (54.5% after 12 months). Lesion activity assessment has shown significant difference between the three groups with the greatest reduction of lesion activity among the P11-4. Multilevel regression showed non-significant reduction of ICDAS in P11-4 and NSF varnishes compared to NaF varnish (AOR = 2.256, 95% CI: 0.58–8.77 and AOR = 2.119, 95% CI: 0.588,-7.636 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