NCT06749977

P11-4 and Fluoride Varnish for Remineralization of Post-orthodontic Lesions

Efficacy of Self-assembling Peptide P11-4 for the Treatment of Orthodontically Induced Initial Carious Lesions: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Medical University of Sofia · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This clinical study aims to compare the remineralizing effects of self-assembling peptide P11-4 (SAP11-4) with fluoride varnish in the treatment of post-orthodontic non-cavitated carious lesions (NCLs). The study uses the QLF camera to assess changes in lesion size, severity, and mineralization, evaluating the effectiveness of SAP11-4 in comparison to fluoride varnish or no treatment. The primary endpoint is the change in QLF parameters, alongside ICDAS scores and Nyvad criteria for clinical evaluation.

Detailed description

NCLs are common after orthodontic treatment and can persist as white spot lesions, presenting an aesthetic concern. Fluoride is a standard treatment, but it primarily benefits the outer enamel surface, while SAP11-4 may potentially enhance remineralization within the lesion body by mimicking enamel matrix proteins. This clinical study seeks to compare the effectiveness of two treatments for post-orthodontic non-cavitated carious lesions (NCLs): self-assembling peptide P11-4 (SAP11-4) and fluoride varnish. The goal is to evaluate which treatment is more effective at promoting remineralization of these lesions. The study utilizes the Quantitative Light-induced Fluorescence (QLF) camera to monitor changes in lesion size, severity, and mineralization. This method allows for a detailed assessment of the effectiveness of SAP11-4 compared to fluoride varnish or no treatment at all. The primary outcome of the study is the change in QLF parameters, which will be measured alongside the International Caries Detection and Assessment System (ICDAS) scores and the Nyvad criteria, providing a comprehensive clinical evaluation of the treatments' effects on the carious lesions.

Conditions

• White Spot Lesions

Interventions

Type	Name	Description
DRUG	Remineralization with SAP11-4	The WSL were treated with SAP11-4 according to the manufacturer's instruction
DRUG	Remineralization with sodium fluoride varnish	The WSL were treated with sodium fluoride varnish according to the manufacturer's instruction

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-01-01
• Completion: 2023-02-20
• First posted: 2024-12-27
• Last updated: 2024-12-27

Locations

1 site across 1 country: Bulgaria