Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries

Proximal Caries Clinical Trial

Official title: Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries: A Randomized Controlled Clinical Trial

Status Completed

Clinical Trial Summary

The aim of this randomized controlled, double-blinded, split-mouth clinical trial was to evaluate the efficacy of self-assembling peptide P11-4 solution (Curodont™ Repair) with fluoride varnish on the progression of non-cavitated proximal caries compared to casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) with fluoride varnish (MI Varnish™) sodium fluoride (NaF) varnish (Profluorid® Varnish).

The study included 300 permanent molars belonging to 150 children, aged between 7 to 13 years old, who had two non-cavitated proximal carious lesions.

Clinical Trial Description

First, the subjects were randomly allocated to three main groups with 50 individuals in each. Then the carious lesions belonging to each subject were randomly assigned to two subgroups based on different treatment agents used: Group 1; P11-4+NaF/NaF, Group 2; P11-4+NaF/CPP-ACP+NaF, Group 3; CPP-ACP+NaF/NaF. Accordingly, test 1 lesions received P11-4+NaF combination, test 2 lesions received CPP-ACP+NaF varnish, and control lesions received NaF varnish alone. At the 6th and 12th months after the clinical applications, Profluorid® Varnish application was repeated for test 1 and control lesions, and MI Varnish™ application was repeated for test 2 lesions. At the end of the 12 months, carious lesion progression status was evaluated radiographically, by using independent visual reading, pair-wise visual reading, and digital subtraction radiography (DSR) methods. ;

Related Conditions & MeSH terms

• Disease Progression
• Proximal Caries

• NCT number: NCT04776785
• Study type: Interventional
• Source: Izmir Katip Celebi University
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Completion date: January 8, 2021