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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-18
SponsorMedical University of Warsaw

About this trial

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

Qualifiers

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).

Vital pulp,

no loss of hard dental tissues within the investigated lesion (ICDAS II) code 1 or 2 , LAA code 1, ICDAS-LAA>7;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Self-assembling peptide P11-4
  • Fluoride varnish

Treatment groups

75 Participants
are divided into 3 treatment groups

Sponsors and collaborators