RecruitingNot ApplicableNCT07664046

The Effectiveness of the Self-Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions

A Three-arm Randomized Controlled Trial Evaluating the Effectiveness of Self- Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions

Sponsor

Medical University of Warsaw

Enrollment

75 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

White Spot Lesions on Smooth Surface of Tooth

Summary

This is three-arm Randomized Controlled Trial. The main goal is to evaluate the effectiveness of self-assembling peptide P11-4 (SAP P11-4) in the remineralization of enamel carious white spot lesions. Participants with carious white spot lesions will be assigned to one of three study groups and remineralisation agents will be applied according to the study protocol. The primary objective is to assess changes in the carious white spot lesions over time using quantitative light-induced fluorescence and clinical evaluation.

Eligibility

Min Age: 10 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Fluoride varnish and Self-assembling peptide P11-4 for people with white spot lesions on smooth surface of tooth. The study is currently recruiting participants at 1 location. People eligible for this study include aged 10 Years to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERSelf-assembling peptide P11-4

Self-assembling peptide P11-4 will be applied on enamel carious white spot lesions according to the study protocol. In the single-application group (group A), the agent will be applied once at the first visit(baseline). In the repeated-application group (group B), the agent will be applied at the first visit (baseline) and after 3 months.

OTHERFluoride varnish

Fluoride varnish will be applied every 3 months according to the study protocol.

Locations(1)

University Clinical Center of the Medical University of Warsaw, Department of Pediatric Dentistry

Warsaw, Masovian Voivodeship, Poland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07664046