Clinical Trial

Effects of Different Remineralization Agents on the Progression of Non-Cavitated Approximal Carious Lesions in Primary Teeth: A Randomized Clinical Trial

Study acronym: REMİN-PRİMARY
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Dental caries is a highly prevalent disease in children. Contemporary caries management emphasizes minimally invasive approaches that aim to arrest or reverse non-cavitated lesions rather than remove tooth structure. This randomized clinical trial aims to evaluate the effects of different remineralization agents on the progression of non-cavitated approximal carious lesions in primary teeth. The study will be conducted in children aged 4-10 years presenting with non-cavitated approximal carious lesions in primary molars. Participants will be randomly assigned to treatment groups receiving silver diamine fluoride (SDF), a self-assembling peptide (P11-4), and/or 5% sodium fluoride (NaF) varnish. Materials will be applied according to manufacturers' instructions. Lesion progression will be assessed using standardized bitewing radiographs obtained at baseline and follow-up visits. Radiographic evaluations will be performed by blinded investigators. In addition, potential tooth color changes associated with the treatments will be quantitatively measured using a spectrophotometer based on the CIE Lab\* system at predefined follow-up intervals. The findings of this study are expected to provide clinically relevant evidence regarding the effectiveness and aesthetic outcomes of contemporary non-invasive caries management strategies in primary teeth.
Trial Details
NCT Number NCT07431463
Lead Sponsor Izmir Katip Celebi University
Conditions Dental Caries
Enrollment 90 participants
Start Date 2025-10-01
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-24