Objective: We previously reported that a rationally designed biomimetic self-assembling peptide, P₁₁-4, 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 P₁₁-4 on early enamel lesions.
Materials and methods: Fifteen healthy adults with Class V 'white spot' lesions received a single application of P₁₁-4. Adverse events and lesion appearances were recorded over 180 days.
Results: Patients treated with P₁₁-4 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 P₁₁-4 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 P₁₁-4 is safe, and that a single application is associated with significant enamel regeneration, presumably by promoting mineral deposition within the subsurface tissue.