Treatment of early caries lesions using biomimetic self-assembling peptides - a clinical safety trial

Objective We previously reported that a rationally designed biomimetic self-assembling peptide, P-11-4, nucleated hydroxyapatite de novo and was apparently capable of in situ enamel regeneration following infiltration into caries-like lesions. Our present aim was to determine the safety and potential clinical efficacy of a single application of P-11-4 on early enamel lesions. Materials and methods Fifteen healthy adults with Class V 'white spot' lesions received a single application of P-11-4. Adverse events and lesion appearances were recorded over 180 days. Results Patients treated with P-11-4 experienced a total of 11 adverse events during the study, of which two were possibly related to the protocol. Efficacy evaluation suggested that treatment with P-11-4 significantly decreased lesion size (p = 0.02) after 30 days and shifted the apparent progression of the lesions from 'arrested/progressing' to 'remineralising' (p <0.001). A highly significant improvement in the global impression of change was recorded at day 30 compared with baseline (p <0.001). Conclusions The results suggest that treatment of early caries lesions with P-11-4 is safe, and that a single application is associated with significant enamel regeneration, presumably by promoting mineral deposition within the subsurface tissue.