[A randomized clinical trial of two bioceramic materials in primary molar pulpotomies]

Objective: To compare the success rates of iRoot BP Plus and mineral trioxide aggregate (MTA) used as pulp capping materials respectively in pulpotomies of human primary molars and to evaluate the clinical efficacy of iRoot BP Plus. Methods: Children who had at least one pair of carious primary molars and needed to receive pulpotomy under general anesthesia were selected in the present split-mouth trail from August to December, 2018. Each pair of the molars was randomly divided into iRoot BP Plus (experimental group) and MTA group (control group). Children were recalled after 3, 6 and 12 months of treatment both for clinical and radiographic evaluations. Relevant medical and radiographic records were collected. Success rates of two groups were compared and influence factors were analyzed. Results: Totally 20 children (10 boys and 10 girls), 28 pairs of split-mouth molars (56 molars, 28 in experimental group and 28 in control group) were included in the study. At the end of the study, 23 pairs of molars were received the 12-month follow-up. The success rates of 3, 6 and 12 months were 96% (25/26), 92% (22/24) and 87% (20/23) in the experimental group, and 100% (26/26), 96% (23/24), 96% (22/23) in the control group, respectively. There were no significant differences between each of the follow-ups in two groups (P>0.05). The success rate of iRoot BP Plus was significantly influenced by the time of hemostasis after amputating the coronal pulp (P<0.05). Conclusions: Pulpotomies of human primary molars with either iRoot BP Plus or MTA had favorable treatment outcomes. The iRoot BP Plus could be a promising biomaterial in pulpotomy.