Randomised clinical trial investigating self-assembling peptide P11-4 in the treatment of early caries

Objectives This prospective, randomised, split-mouth, clinical trial compared the efficacy of the self-assembling peptide P-11-4 to fluoride varnish in the treatment of early buccal carious lesions. Materials and methods Subjects presenting at least two clinically affected teeth were treated at D0 (day 0) and D90 with P-11-4 (test) or fluoride varnish (control). At D180, fluoride varnish was applied on all study lesions. Standardised photographs were taken at D0, D30, D90, D180 and D360 and blindly morphometrically assessed. Hierarchical linear models (HLM) under allowance of confounders were used to compare the decrease in size between test and control groups. The visual analog scale (VAS) and Global Impression of Change Questionnaire (GICQ) were used as clinical assessments. Results Overall, 37 subjects (13-36 years) with 90 early carious lesions were included. HLM analysis showed a significant difference between test and control groups, indicating a decrease in test lesions and stabilisation of control lesions size (p = 0.001). The test lesion's mean size (SD) relative to baseline decreased to D30 = 0.936(0.127), D90 = 0.874(0.173), D180 = 0.844(0.215) and D360 = 0.862(0.352), whereas control lesions remained stable at D30 = 1.018(0.209), D90 = 1.013(0.207), D180 = 1.029(0.235) and D360 = 1.068(0.401). The effect sizes ranged from 0.47 to 0.82. Conclusions Within the limits of this study, it was shown that the size of early carious lesions treated with P-11-4 was significantly reduced; this result was superior to that of fluoride varnish treatment (DRKS00012941).