Evaluation of the Increase in Dentinal Barrier Thickness Formed by Indirect Pulp Treatment with Two Different Indirect Pulp Capping Agents in Primary Molars: A Randomized Controlled Trial.

AIMS AND BACKGROUND: Indirect pulp treatment (IPT) is a conservative approach to preserving pulp vitality in primary molars with deep carious lesions. This study aimed to compare the increase in dentinal barrier thickness following IPT using two different materials, SafeEndo BioStructure MTA Putty and VOCO Calcimol LC, over a 6-month period. MATERIALS AND METHODS: A single-blinded, parallel-group, randomized controlled clinical trial was conducted among children aged 5-8 years requiring IPT. Eligible teeth were randomly allocated into two groups: Group I and group II. Following caries excavation and restoration, dentinal thickness was measured radiographically at baseline, 3 months, and 6 months using CorelDRAW software (version 13) digital analysis. Data were analyzed using the Mann-Whitney U test and repeated measures analysis of variance (ANOVA). The trial was registered in the Clinical Trial Registry of India (CTRI/2024/11/076988). RESULTS: At baseline, the mean dentin thickness was 0.62 ± 0.25 mm in group I and 0.48 ± 0.20 mm in group II (p = 0.98). At 3 months, increments were 0.70 ± 0.11 mm (group I) and 0.16 ± 0.14 mm (group II; p = 0.93). From 3 to 6 months, both groups showed an additional mean increase of 0.04 ± 0.01 mm (p = 0.49). Over the entire 6 months, the cumulative increase was 0.11 ± 0.02 mm (group I) and 0.10 ± 0.02 mm (group II; p = 0.45). Intragroup analysis revealed significant increases in dentin thickness over time for both groups (p ≤ 0.02). CONCLUSION: Both SafeEndo BioStructure MTA and VOCO Calcimol LC effectively promoted dentinal barrier formation in primary molars, with no statistically significant difference between the two materials over 6 months. Most dentin deposition occurred within the first 3 months, followed by a slower maturation phase. CLINICAL SIGNIFICANCE: The results of this trial will contribute to existing knowledge on IPT agents in pediatric dentistry, guide clinical decision-making, and potentially reduce the need for invasive treatments.