Treatment options for early tooth decay in children
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
This study is testing different treatments for early tooth decay in kids aged 9-17 to see which one works best for fixing white spots on their teeth.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 9 Years to 17 Years |
| Sex | All |
| Sponsor | Plovdiv Medical University Academic / other |
| Locations | 1 site (Plovdiv) |
| Trial ID | NCT05206539 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of different agents, including self-assembling peptide (P11-4), casein phosphopeptide-amorphous calcium fluoride phosphate (CPP-ACFP), and resin infiltration techniques, in treating white spot lesions (WSL) in children aged 9-17. The study employs a randomized controlled design with a split-mouth approach, where participants will receive various treatments on different lesions. Assessments will be conducted using visual criteria and laser fluorescence at multiple follow-up points to determine the success of the treatments in reversing or arresting the lesions.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 9-17 with at least four visible white spot lesions on their permanent teeth that are not cavitated.
Not a fit: Patients with a history of allergy to the medications used in the study or those who have undergone recent remineralizing or topical fluoride therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective non-invasive treatment options for early dental caries in children, potentially preventing the progression to more severe dental issues.
How similar studies have performed: Other studies have shown promise in treating early carious lesions with similar approaches, but this specific combination of treatments is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Plovdiv
- Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv — Plovdiv, Bulgaria (Recruiting)
Study contacts
- Study coordinator: Irina Uzunova, DMD
- Email: iuzunova.raycheva@gmail.com
- Phone: +359899984312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.