Efficacy of a self-assembling peptide to remineralize initial caries lesions - A systematic review and meta-analysis.

INTRODUCTION/OBJECTIVES: The present review systematically analyzed clinical studies investigating the efficacy of self-assembling peptides (SAP) to reduce initiation of or to remineralize initial caries lesions. DATA: Prospective controlled (non-)randomized clinical trials investigating the efficacy of a self-assembling peptide compared to any other (placebo) treatment or untreated/standard control. Outcomes were visual analog scale (VAS), laser fluorescence, ICDAS score or morphometric measurements. SOURCES: Three electronic databases (Central, PubMed, Ovid EMBASE) were screened. No language or time restrictions were applied.. Risk of Bias and level of evidence was graded using Risk of Bias 2.0 tool and Grade Profiler 3.6. STUDY SELECTION/RESULTS: Seven studies with 508 teeth being affected in 294 patients were included. All studies were randomized controlled trials (RCT), five with a split-mouth and two with a parallel-arm design. Meta-analysis could be performed for SAP (plus fluoride varnish (FV)) vs. no treatment (plus FV) (control treatment). Depending on the outcome after up to 12 months SAP showed a significantly higher optical improvement than the control treatment (laser fluorescence: Standardized Mean Difference (SMD)[95 %CI] = -0.87[-1.39,-0.34; VAS: Mean Difference (MD)[95 %CI] = -35.38[-43.13,-27.64]) or no significant difference could be observed (ICDAS/activity score; Relative Risk (RR)[95 %CI] = 0.6[0.21,1.74]; morphometric measurements: SMD[95 %CI] = -1.95[-4.54,0.65]). Level of evidence was very low for all 4 outcomes. Furthermore, six studies showed a high risk of bias and six studies were (partially) funded by the manufactures of the tested products. CONCLUSION: Based on a low number of clinical trials with relatively short follow up-periods and high risks of bias, self-assembling peptides may be a viable option to remineralize enamel caries. CLINICAL SIGNIFICANCE: Self-assembling peptides may be a viable option to remineralize enamel caries. However, results should be interpretated with caution due the low number of clinical trials, the short follow-up periods and the limiting grade of evidence.