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Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial
Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions
Patient/population: Patients that range from 7-14 years of age with with at least one non-cavitated WSL located on smooth surfaces of maxillary or mandibular permanent teeth and comparable in size, opacity, and whitish appearance. Intervention: I1: Self-Assembling Peptide (P11-4) I2: Self-Assembling Peptide (P11-4) with fluoride varnish Comparator Resin Infiltration Outcome: Primary outcome * Esthetic Improvement of white spot lesion Outcome measure: Photographic analysis Outcome measuring Device: Image analysis to calculate change in area ratio of WSL to the labial surface using Photoshop software. Outcome measuring unit: change in Percentage • Tooth remineralization 1. Outcome measure: International Caries Detection and Assessment System (ICDAS) score. Outcome measuring Device: Visual and Clinical examination by operator Outcome measuring Unit : Numerical score from 0-6 2. Outcome measure: Quantitative light Fluorescence score from WSL Outcome measuring Device: Diagnodent Pen Outcome measuring Unit: Numerical score from 0-99 Secondary outcome Outcome measure: Patient Satisfaction Outcome measuring Device Likert 5-point faces scale ranging from very sad to very happy Outcome measuring Unit :Numerical score from 1-5 Study design: Randomized clinical trial Time: 6 months
Age
7 - 14 years
Sex
ALL
Healthy Volunteers
Yes
October 6 University
Cairo, Giza Governorate, Egypt
Start Date
August 30, 2024
Primary Completion Date
February 1, 2025
Completion Date
February 1, 2025
Last Updated
November 27, 2024
150
ESTIMATED participants
P11-4, a self-assembling peptide
DRUG
P11-4, a self-assembling peptide with flouride
DRUG
resin infilteration
DRUG
Lead Sponsor
October 6 University
Collaborators
NCT06696105
NCT06824493
Data Source & Attribution
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