Systematic review and meta-analysis on the effect of self-assembling peptide P₁₁-4 on arrest, cavitation, and progression of initial caries lesions

Background: Simple noninvasive evidence-based interventions for caries are needed to overcome limitations in the restorative paradigm. The self-assembling peptide P₁₁-4 is a noninvasive intervention that regenerates enamel in initial caries lesions. Studies Reviewed: The authors conducted a systematic review and meta-analysis on the effectiveness of the P₁₁-4 products Curodont Repair (Credentis; now manufactured by vVARDIS) (CR) and Curodont Repair Fluoride Plus (Credentis; now manufactured by vVARDIS) on initial caries lesions. Primary outcomes were lesion progression after 24 months, caries arrest, and cavitation. Secondary outcomes were changes in merged International Caries Detection and Assessment System score categories, quantitative light-induced fluorescence (QLF; Inspektor Research System), esthetic appearance, and lesion size. Results: Six clinical trials met the inclusion criteria. Results of this review represent 2 primary and 2 secondary outcomes. When compared with parallel groups, use of CR likely results in a large increase in caries arrest (relative risk [RR], 1.82 [95% CI, 1.32 to 2.50]; 45% attributable risk [95% CI, 24% to 60%]; number needed to treat [NNT], 2.8) and likely decreases lesion size by a mean (SD) of 32% (28%). The evidence also suggests that use of CR results in a large reduction in cavitation (RR, 0.32 [95% CI, 0.10 to 1.06]; NNT, 6.9) and is uncertain about lowering merged International Caries Detection and Assessment System score (RR, 3.68 [95% CI, 0.42 to 32.3]; NNT, 19). No studies used Curodont Repair Fluoride Plus. No studies reported adverse esthetic changes. Practical Implications: CR likely has clinically important effects on caries arrest and decreased lesion size. Two trials had nonmasked assessors, and all trials had elevated risks of bias. The authors recommend conducting longer trials. CR is a promising treatment for initial caries lesions. The protocol for this systematic review was registered a priori with PROSPERO (304794).