Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07664046
NA

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

Sponsor: Medical University of Warsaw

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

10 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-02-02

Completion Date

2027-12-14

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

OTHER

Self-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.

OTHER

Fluoride 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