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

MU_WSL

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.

2024-06-01

2025-03-01

2025-04-01

Recruiting

Early phase I

40

Inclusion Criteria: * Participants in the study are children 9 to 17 years old. * Obtained written informed consent from parents or gave-givers as well as obtained verbal informed consent from the child to participate in the study, in which procedures are explained in age-appropriate manner. * Children, identified as positive or definitely positive through Frankl behavioral rating scale. * Presence of at least four initial carious lesions of smooth surface (white spots) in permanent teeth that reach the inside of the enamel but are not cavitated, estimated with ICDAS system values 01 (first visible enamel change) and 02 (localized visible enamel change), Nyvad caries activity criteria (1 -active, noncavited lesion) and DIAGNOdent pen values up to 24. * Study participants did not conduct remineralizing or topical fluorine therapy of the lesions involved up to six months prior to inclusion in the study. * Children without a history of allergy to the administered medications Exclusion Criteria: * Patients with general diseases or conditions associated with decreased salivation and intake of medications suppressing salivary current. Children with cognitive and behavioral disorders. The presence of a disease is confirmed by an anamnestic interview with the parent. * Children with a history of allergy to the administered medications * Patient with non-carious lesion such as enamel hypoplasia, or any developmental defects. * Patient received restorations or any remineralizing agent other than the regular toothpaste during the last 6 months. * Participant in another trial.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The trial to be conducted is a randomized controlled clinical crossover experimental study with split-mouth design. The within-subject design randomly allocates experimental and control interventions to different areas in the oral cavity (teeth, surfaces, arches, quadrants) and has the advantage of reducing outcome variability estimation since each patient is its own control, leading to potential increase in statistical power.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'This is a double-blinded trial, i.e., where patients and outcomes assessor are not aware which white spot lesion what treatment will receive, unlike the operator which is not blinded for the study due to the nature of the investigated techniques.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-05-09