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The Effectiveness of the Self-Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions
Sponsor: Medical University of Warsaw
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
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.
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