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NCT07664046
The Effectiveness of the Self-Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions
Conditions: White Spot Lesions on Smooth Surface of Tooth
Sex: All
Ages: 10 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 75
Sponsor: Medical University of Warsaw
Location: University Clinical Center of the Medical University of Warsaw, Department of Pediatric Dentistry Warsaw Masovian Voivodeship
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 Criteria
Inclusion Criteria:
1. Age \>10 years and \7;
3. QLF score parameters consistent with demineralization without loss of tissue continuity- code 1 or 2),
4. no history of trauma to the tooth.
4. Systemically healthy patient.
5. No contraindications to the use of fluoride preparations.
6. No fixed orthodontic appliance.
7. Written consent for participation in the study signed by the legal guardian, or by the legal guardian and the patient.
Exclusion Criteria:
1. Systemic diseases or chronic medication use due to chronic conditions.
2. Viral/bacterial illness on the day of the visit, e.g., herpetic stomatitis, influenza, tonsillitis (temporary restriction).
3. Pregnancy or breastfeeding.
4. Allergy to any component of the SAP P11-4 preparation or the fluoride varnish.
5. Professional fluoride prophylaxis performed \
Source: ClinicalTrials.gov (NCT07664046). StuddyBuddy aggregates publicly available trial information.