Eur Arch Paediatr Dent. 2023 Sep 13. doi: 10.1007/s40368-023-00821-2. Online ahead of print.
PURPOSE: The primary objective of the review was to assess the effectiveness of self-assembling P11-4 peptide (SAP) with or without any fluoride agents (FA) in remineralization of the White spot lesions (WSLs)/incipient carious lesions (ICLs) compared to other enamel remineralizing agents/non-intervention/placebo.
METHODS: Human RCTs published during the period from 1st January 2000-30th June 2021 were searched in the electronic bibliographic databases and scanning reference lists of articles from PubMed, Google Scholar, and The Cochrane Central Register of Controlled Trials. The Risk-of-Bias was assessed using version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2) tool for all included studies. The statistical heterogeneity between studies was assessed by the Cochrane Q test and I2 test. A random-effects model was used considering the variations in true effects size between the included studies. The quality of the evidence for remineralizing effectiveness of SAP/SAP + FA was done using the GRADEpro GDT software which employs GRADE.
RESULTS: Four out of eight included trials were assessed to have “high risk” of bias. Mean difference for Laser fluorescence outcome assessment method (SAP v/s FA) was – 4.89 (95% CI: – 17.35 to 7.57; p = 0. 44; I2 = 89%). The combined risk ratio observed through Nyvad criteria (SAP v/s FA) was 0.12 (95% CI: 0.01-1.59; p = 0.11; I2 = 71%). Mean difference for Laser fluorescence outcome assessment method (SAP + FA v/s FA) was – 11.52 (95% CI: – 14.43 to – 8.61; p = < 0.001;I2 = 0%). The combined risk ratio for ICDAS outcome assessment method (SAP + FA v/s FA) was 0.27 (95% CI: 0.03-2.84; p = 0.15; I2 = 53%).
CONCLUSION: Considering the results observed from the included trials we are uncertain whether SAP/SAP + FA increases/decreases the remineralizing/regeneration of WSLs/ICLs.