Abstract
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.
Highlights
Objective We previously reported that a rationally designed biomimetic self-assembling peptide, P ‐4, nucleated hy[11] droxyapatite de novo and was apparently capable of in situ enamel regeneration following infiltration into caries-like lesions
Conclusions The results suggest that treatment of early caries lesions with P ‐4 is safe, and that a single application is associated with 11 significant enamel regeneration, presumably by promoting mineral deposition within the subsurface tissue
We are continuing to further our understanding of the kinetics and physicochemical properties of these materials
Summary
Summary of: Treatment of early caries lesions using biomimetic self-assembling peptides – a clinical safety trial.
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