Self-assembling Peptide P₁₁-4 and Fluoride for Regenerating Enamel

Abstract

Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy. In vitro, self-assembling peptide P-4 enhances remineralization of early carious lesions. To investigate the safety and clinical efficacy of P-4 for treatment of initial caries, a randomized controlled single-blind study was conducted on children aged >5 y with visible active early caries on erupting permanent molars. Subjects were randomized to either the test group (P-4 + fluoride varnish) or control group (fluoride varnish alone). Caries were assessed at baseline and at 3 and 6 mo posttreatment per laser fluorescence, a visual analog scale, the International Caries Detection and Assessment System, and Nyvad caries activity criteria. Intention-to-treat analyses were performed, and safety and clinical feasibility of the treatment approaches were assessed. Compared with the control group, the test group showed clinically and statistically significant improvement in all outcomes at 3 and 6 mo. The laser fluorescence readings (odds ratio = 3.5, P = 0.015) and visual analog scale scores (odds ratio = 7.9, P < .0001) were significantly lower for the test group, and they showed regression in the International Caries Detection and Assessment System caries index (odds ratio = 5.1, P = 0.018) and conversion from active to inactive lesions according to Nyvad criteria (odds ratio = 12.2, P < 0.0001). No adverse events occurred. The biomimetic mineralization facilitated by P-4 in combination with fluoride application is a simple, safe, and effective noninvasive treatment for early carious lesions that is superior to the presently used gold standard of fluoride alone. By regenerating enamel tissue and preventing lesion progression, this novel approach could change clinical dental practice from a restorative to a therapeutic approach. This could avoid additional loss of healthy hard tissue during invasive restorative treatments, potentially enabling longer tooth life and thereby lowering long-term health costs ( ClinicalTrials.gov NCT02724592).

Effect of self-assembling peptide P11-4 on orthodontic treatment-induced carious lesions

“…Our trial raised comparable parameters as the previously reported trials [25][26][27]32 but differs from the other trials on buccal caries, as active carious lesions (clinically visible as rough, chalky and matte surface) were treated, and not predominantly inactive ones (clinically visible as a white spot under a hard, shiny surface) [25][26][27] . Both the impedance values and morphometric measurements showed favourable WSL reduction results for the test group.…”

State of the Art Enamel Remineralization Systems: The Next Frontier in Caries Management

“…The P11-4-treated carious lesions showed a significantly improved visual appearance and increased radiographic opacity, remaining stable even 6-12 months after treatment [Schlee et al, 2014[Schlee et al, , 2018. A recent randomized controlled trial (RCT) demonstrated that biomineralization facilitated by P11-4 in combination with fluoride is safe and more effective than the present clinical gold standard of fluoride treatment alone [Alkilzy et al, 2018b].…”

“…Presently, there is an attempt to shift from reparative to regenerative biomineralization therapies, wherein diseased dental tissues are replaced with biologically similar tissues [Alkilzy et al, 2018b]. Enamel regeneration is however particularly challenging as mature enamel is acellular and does not resorb or remodel itself unlike bone or dentine [Moradian-Oldak, 2012].…”

Self Assembly Peptides- Biomimetic Material

“…In a study remineralization of natural carious lesions in human teeth, were monitored using the Canary System. Canary Number of 40-50 (early carious lesions) remained basically unchanged for both control groups, but it reduced to values only slightly higher than that of sound enamel for the P11-4 group showing the remineralizing capacity of self assembling peptide P11-4 [10].…”