CompletedNot Applicable

Remineralization of White Spot Lesions Using Self-Assembling Peptide P11-4 in Primary Anterior Teeth A Randomized Clinical Trial

Egypt11 participantsStarted 2020-09-01

Plain-language summary

This study is a randomized controlled clinical trial on primary anterior teeth of 3-5 year-old patients suffering from white spot lesions (ICDAS system II scores 1-2). Forty four teeth will be divided into two groups where Group 1 (n=22 teeth) will receive Self-Assembling Peptide P11-4. Group 2 (n=22 teeth) will receive Topical Fluoride Varnish Application. Assessment will be done at baseline using the International Caries Detection and Assessment System II (ICDAS II) scoring system and Light Induced Fluorescence using Soprolife System (Acteon, La Ciotat, France) and then after 3 months, 6 months and 1 year. The assessment of the baseline and follow up data will be performed by the main investigator.

Who can participate

Age range3 Years – 5 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy patients ASA Class I. * ≥1 Primary Anterior Teeth with early carious lesions of ICDAS scores 1-2. * Subjects whose parents are willing and able to maintain good oral hygiene for their children and attend study visits. * Patients aged between 3-5 years. * Subjects with a minimum of 1 and a maximum of 12 primary anterior teeth with early carious lesions of ICDAS II scores 1-2. Exclusion Criteria: * Primary anterior teeth in which carious lesions are scored with ICDAS ≥3. * Subjects on medication that affects the salivary flow rate.

What they're measuring

Remineralization of white spot lesions

Timeframe: One year

Trial details

NCT IDNCT03927794

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-01