💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age \>10 years and \<18 years.
2. 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).
3. Tooth eligible for treatment:
1. Vital pulp,
2. no loss of hard dental tissues within the investigated lesion (ICDAS II) code 1 or 2 , LAA code 1, ICDAS-LAA\>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 \<3 months ago.
6. Presence of cavitation (loss of hard tissues) in the treated tooth - ICDAS II code ≥3, ICDAS-LAA\<7, LAA code 0, 2-9.
7. Carious WSL previously treated with the Icon resin infiltrant (methacrylate resin).
8. Developmental enamel defects.
9. Patient undergoing orthodontic treatment with fixed appliances.
10. Inability to ensure regular follow-up visits.
11. Lack of cooperation from the guardian or the patient.
12. Refusal to participate in the study and/or absence of written consent.
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