Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children
Launched by PLOVDIV MEDICAL UNIVERSITY · Jan 12, 2022
Trial Information
Current as of November 05, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at different treatments for white spot lesions (WSL) on the teeth of children. WSLs are early signs of tooth decay that appear as white patches on the teeth, but the surface remains intact. The study aims to find out how effective three different treatments—self-assembling peptide (P11-4), casein phosphopeptide-amorphous calcium fluoride phosphate (CPP-ACFP), and resin infiltration—are at reversing or stopping these lesions in children aged 9 to 17 years. Researchers will use visual checks and a special laser tool to assess the effectiveness of these treatments.
To participate, children need to be between 9 and 17 years old and have at least four white spot lesions on their permanent teeth that are not cavitated (not formed holes). Parents or guardians must give written consent, and children need to agree in a way that makes sense to them. It’s important for children to not have had any treatments like fluoride therapy on those spots in the past six months and to not have allergies to the study medications. Participants will be closely monitored throughout the trial, and their progress will be evaluated using specific tools to ensure the best care and results.
Gender
ALL
Eligibility criteria
- 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.
About Plovdiv Medical University
Plovdiv Medical University is a distinguished academic institution dedicated to advancing medical education, research, and clinical practice. With a robust commitment to scientific innovation and public health, the university actively engages in clinical trials to enhance therapeutic interventions and patient outcomes. By fostering collaborations with healthcare professionals and researchers, Plovdiv Medical University aims to contribute significantly to the body of medical knowledge and improve healthcare delivery through rigorous clinical research. Its state-of-the-art facilities and comprehensive training programs ensure that the institution remains at the forefront of medical advancements in the region and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Plovdiv, Bulgaria
Patients applied
Trial Officials
Ani Belcheva, PhD
Study Director
Medical University Plovdiv, Bulgaria
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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