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Randomized Clinical Trial investigating Self-Assembling Peptide P₁₁-4 for Treatment of Early Occlusal Caries.

ABSTRACT: Non-invasive caries treatment is a major focus in modern dentistry. The present study was designed to evaluate the effectiveness of monomeric self-assembling peptide P₁₁-4 (SAP P₁₁-4) in combination with fluoride varnish or polymeric self-assembling peptide matrix (SAPM) in treatment of non-cavitated occlusal caries. Ninety children and adolescents were included in this randomized, gold-standard-controlled clinical trial. Test Group 1 received SAP P₁₁-4 and twice fluoride varnish at baseline and Day 180, Test Group 2 received SAP P₁₁-4 on baseline and twice weekly SAPM (home-application), and Control Group received fluoride varnish on baseline and Day 180. Caries progression was measured by laser fluorescence, Nyvad Caries Activity, ICDAS-II-codes, and investigator assessments. Laser fluorescence changes demonstrated superior results for Test Group 1 and 2, as values decreased compared to an increase for the Control Group (p < 0.0005). ICDAS-II codes at Day 360 showed partial regression for Test Group 1 (6.7%) and Test Group 2 (20.0%) and partial progression for Control Group (23.3%) (p < 0.01). Nyvad Caries Activity yielded superior caries inactivation for Test Groups, compared to Control Group (p = 0.002). This trial showed that SAP P₁₁-4, applied either in combination with fluoride varnish or twice weekly SAPM, was a superior treatment for early caries compared to fluoride varnish alone.

SUBMITTER: Doberdoli D

PROVIDER: S-EPMC7060217 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Randomized Clinical Trial investigating Self-Assembling Peptide P11-4 for Treatment of Early Occlusal Caries.

Doberdoli Dafina D Bommer Claudine C Begzati Agim A Haliti Fehim F Heinzel-Gutenbrunner Monika M Juric Hrvoje H

Scientific reports 20200306 1

Non-invasive caries treatment is a major focus in modern dentistry. The present study was designed to evaluate the effectiveness of monomeric self-assembling peptide P11-4 (SAP P11-4) in combination with fluoride varnish or polymeric self-assembling peptide matrix (SAPM) in treatment of non-cavitated occlusal caries. Ninety children and adolescents were included in this randomized, gold-standard-controlled clinical trial. Test Group 1 received SAP P11-4 and twice ...[more]

PMID: 32144336

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Project description: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 P11-4 enhances remineralization of early carious lesions. To investigate the safety and clinical efficacy of P11-4 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 (P11-4 + 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 P11-4 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).

Dataset Information

Randomized Clinical Trial investigating Self-Assembling Peptide P₁₁-4 for Treatment of Early Occlusal Caries.

Publications

Randomized Clinical Trial investigating Self-Assembling Peptide P<sub>11</sub>-4 for Treatment of Early Occlusal Caries.

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