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Efficacy of Self-assembling Peptide P11-4, Casein Phosphopeptide - Amorphous Calcium Fluoride Phosphate and Resin Infiltrant in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children
White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries. Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients using visual assessments and laser fluorescence investigation.
White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries. These lesions are characterized by white chalky appearance. As caries is reversible under favorable conditions, many approaches have focused on treating it as soon as possible1. Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients. This will be achieved using visual assessments and laser fluorescence investigation. The proposed study is a randomized controlled clinical trial with split-mouth design. Included are forty positive patients aged 9-17 years, with at least four visible WSL on smooth surfaces in permanent teeth, requiring non-operative treatment. WSL will be assessed visually by ICDAS II, Nyvad criteria and laser fluorescence (LF pen). The lesions are randomly assigned into 4 groups (n = 40): Gr NT (no treatment, control group), Gr CR (Curodont Repair), Gr V (MI Varnish), Gr I (Icon) groups. Lesions will be assessed by International Caries Detection and Assessment System, Nyvad caries activity criteria and laser fluorescence at baseline and follow-up period after1, 3, 6 and 12 months. Data will be analyzed with intention-to-treat concept by Student T-test for paired samples, Wilcoxon signed rank test, P\< .05. Pre-test on 20 subjects resulted in n=41 patients sample size.
Age
9 - 17 years
Sex
ALL
Healthy Volunteers
Yes
Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv
Plovdiv, Bulgaria
Start Date
June 1, 2024
Primary Completion Date
March 1, 2025
Completion Date
April 1, 2025
Last Updated
May 9, 2024
40
ESTIMATED participants
Self-assembling peptide (P11-4)
DRUG
CPP-ACFP
DRUG
Resin infiltration
DRUG
Control Group, No Treatment
OTHER
Lead Sponsor
Plovdiv Medical University
NCT06986551
NCT06797882
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