Abstract
BACKGROUND: This study aimed to compare the efficacy of BRIX3000, Carisolv, and the conventional rotary-mechanical method for caries removal and to evaluate the intraoperative pain level and the requirement for local anesthesia during caries excavation in immature mandibular permanent first molars (PFMs) of pediatric patients aged 7 to 9. MATERIALS AND METHODS: It was a single-blinded, randomized, parallel-group, active-controlled trial with three arms. Forty-five specimens were assigned randomly to three groups: Group 1: Chemomechanical caries removal (CMCR) utilizing Carisolv. Group 2: CMCR utilizing BRIX3000. Group 3: Control group, caries excavation utilizing conventional rotary-mechanical method. Lesions reaching the middle or inner third of the dentine (D2/3) were observed in immature mandibular PFMs with no pulpal and/or periodontal issues included. The efficacy of caries removal was considered the primary outcome measure. It was recorded using the Ericson et al. scale by visual-tactile examination and the caries detector, which includes five levels to rate the amount of carious dentin remaining. The secondary outcome measures were subjective and objective pain assessment and the requirement of local anesthesia. Continuous and categorical data were compared using the Kruskal-Wallis and chi-square tests, respectively. A significance level of p < 0.05 was adjusted. RESULTS: All conventional-method cases (100%) and the majority of Carisolv and BRIX3000 cases (80%) showed complete caries removal and a mean score of (0.27 ± 0.59) and (0.20 ± 0.41) (p = 0.185), respectively. The conventional method group showed the highest mean score (2.07 ± 0.88) of the sound, eye, motor (SEM) scale compared with the Carisolv and BRIX3000 (p < 0.05) groups, which exhibit lower mean scores (0.80 ± 0.77), (0.67 ± 0.72), respectively. For the Wong-Baker FACES scale, the conventional method group recorded the highest mean (7.07 ± 3.01) compared to the Carisolv and BRIX3000 (p < 0.05) groups, which had considerably lower mean scores of (2.53 ± 2.77) and (2.00 ± 2.39), respectively. Consequently, the majority (80.00%) of conventional-method cases asked for local anesthesia (p < 0.05). CONCLUSIONS: All methods were equally effective in removing caries. BRIX 3000 and Carisolv agents notably reduced pain in children. TRIAL REGISTRATION: ISRCTN registry, ISRCTN12761284, registered 6 November 2024, retrospectively.