Remineralizing White Spot Lesions with P11-4: A three-arm trial

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, three-arm study enrolls participants aged 10-18 with active white spot lesions on smooth surfaces. Participants are assigned to receive either a single P11-4 application plus quarterly fluoride varnish, repeated P11-4 applications with quarterly fluoride varnish, or quarterly fluoride varnish alone. Remineralization is assessed over a one-year period using quantitative light-induced fluorescence and clinical exams. The trial is conducted at the Department of Pediatric Dentistry, Medical University of Warsaw, with follow-ups every three months. The primary goal is to determine changes in lesion mineral content and appearance over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Clinical Center of the Medical University of Warsaw, Department of Pediatric Dentistry
  Warsaw, Masovian Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Dorota Olczak-Kowalczyk, Prof. — Medical University of Warsaw
• Study coordinator: Anna Turska-Szybka
• Email: pedodoncja@wum.edu.pl
• Phone: +48 22 116 64 24

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.