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

Recruiting now · Not applicable

Conditions studied: White Spot Lesions on Smooth Surface of Tooth

In brief

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.

Key facts

Study ID

NCT07664046

Run by

Medical University of Warsaw

People needed

75

Starts

2026-02-02

Expected to finish

2027-12-14

Last updated by the study team

2026-06-23

Who can join

Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >10 years and <18 years.
• Presence of at least 2 active enamel carious white spot lesions on a smooth tooth surface (labial/buccal surfaces of permanent teeth) based on International Caries Detection (ICDAS II) and Assessment System -Lesion Activity Assessment (ICDAS-LAA), and Lesion Activity Assessment (LAA criteria).
• Tooth eligible for treatment:
• Vital pulp,
• no loss of hard dental tissues within the investigated lesion (ICDAS II) code 1 or 2 , LAA code 1, ICDAS-LAA>7;
• QLF score parameters consistent with demineralization without loss of tissue continuity- code 1 or 2),
• no history of trauma to the tooth.
• Systemically healthy patient.
• No contraindications to the use of fluoride preparations.
• No fixed orthodontic appliance.
• Written consent for participation in the study signed by the legal guardian, or by the legal guardian and the patient.

You may not qualify if…

• Systemic diseases or chronic medication use due to chronic conditions.
• Viral/bacterial illness on the day of the visit, e.g., herpetic stomatitis, influenza, tonsillitis (temporary restriction).
• Pregnancy or breastfeeding.
• Allergy to any component of the SAP P11-4 preparation or the fluoride varnish.
• Professional fluoride prophylaxis performed <3 months ago.
• Presence of cavitation (loss of hard tissues) in the treated tooth - ICDAS II code ≥3, ICDAS-LAA<7, LAA code 0, 2-9.
• Carious WSL previously treated with the Icon resin infiltrant (methacrylate resin).
• Developmental enamel defects.
• Patient undergoing orthodontic treatment with fixed appliances.
• Inability to ensure regular follow-up visits.
• Lack of cooperation from the guardian or the patient.
• Refusal to participate in the study and/or absence of written consent.

Where it is running

• University Clinical Center of the Medical University of Warsaw, Department of Pediatric Dentistry — Warsaw, Masovian Voivodeship, Poland (enrolling)

Full record on ClinicalTrials.gov

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