OBJECTIVE: To assess and compare the clinical and radiographic success rates of biodentine and formocresol for pulpotomy in human primary teeth. METHOD AND MATERIALS: A randomized, split-mouth, double-blind, controlled clinical trial was carried out in 37 healthy 4- to 8-year-old children with 56 pairs (112 teeth) of contralateral primary molars indicated for pulpotomy. Matched teeth in each pair were randomized to undergo either biodentine (n = 56 teeth) or formocresol (n = 56 teeth) pulpotomy. In both groups, the teeth were restored with stainless steel crowns. The teeth were evaluated clinically and radiographically at 3 and 6 months by two blinded, standardized, and calibrated examiners. The data were analyzed using chi-square and McNemar tests with a P value of < .05 considered significant. RESULTS: At both the 3- and 6-month follow-ups, all the 37 children with 112 treated teeth were evaluated. Clinical and radiographic success was similar for biodentine (100%) and formocresol (100%), without any statistically significant difference (P = 1). Pulp canal obliteration was radiographically observed in 10/56 (17.9%) and 7/56 (12.5%) cases in the biodentine and formocresol groups, respectively. CONCLUSION: Both pulpotomy techniques showed favorable clinical and radiographic outcomes at 3 and 6 months posttreatment without any significant difference. Hence, biodentine has the potential to become a substitute for formocresol in primary molar pulpotomies.
RCT Entities:
OBJECTIVE: To assess and compare the clinical and radiographic success rates of biodentine and formocresol for pulpotomy in human primary teeth. METHOD AND MATERIALS: A randomized, split-mouth, double-blind, controlled clinical trial was carried out in 37 healthy 4- to 8-year-old children with 56 pairs (112 teeth) of contralateral primary molars indicated for pulpotomy. Matched teeth in each pair were randomized to undergo either biodentine (n = 56 teeth) or formocresol (n = 56 teeth) pulpotomy. In both groups, the teeth were restored with stainless steel crowns. The teeth were evaluated clinically and radiographically at 3 and 6 months by two blinded, standardized, and calibrated examiners. The data were analyzed using chi-square and McNemar tests with a P value of < .05 considered significant. RESULTS: At both the 3- and 6-month follow-ups, all the 37 children with 112 treated teeth were evaluated. Clinical and radiographic success was similar for biodentine (100%) and formocresol (100%), without any statistically significant difference (P = 1). Pulp canal obliteration was radiographically observed in 10/56 (17.9%) and 7/56 (12.5%) cases in the biodentine and formocresol groups, respectively. CONCLUSION: Both pulpotomy techniques showed favorable clinical and radiographic outcomes at 3 and 6 months posttreatment without any significant difference. Hence, biodentine has the potential to become a substitute for formocresol in primary molar pulpotomies.