Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: a multi-center randomized controlled trial.

OBJECTIVE

To conduct a randomized clinical trial to compare the post-operative pain experience as well as clinical and radiographic outcomes of pulpotomy in human permanent molars with irreversible pulpitis using calcium enriched mixture (CEM) cement or mineral trioxide aggregate (MTA).

MATERIALS AND METHODS

A total of 413 patients met the inclusion criteria and consented to participate. The patients were randomly allocated into two study arms: MTA pulpotomy (PMTA: n = 208) and CEM pulpotomy (PCEM: n = 205). Numerical rating scale questionnaires were utilized by the patients to record pain intensity (PI) over 7 days post-operatively. The patients were followed-up for 12 months to assess the clinical and radiographic outcomes of treatment. The data was analyzed using Chi-square, Cohen's kappa and t-tests.

RESULTS

There was no significant difference in the mean PI recorded during the 7 post-operative days between the two study arms (p = 0.221). The clinical and radiographic success rates for PMTA at 12-month follow-up were 98 and 95%, respectively; and 97 and 92% for PCEM, respectively. There was no significant differences in clinical (p = 0.7) and radiographic (p = 0.4) success rates between the two arms.

CONCLUSIONS

Excellent treatment outcomes occurred in molar teeth with irreversible pulpitis undergoing pulpotomy with MTA and CEM biomaterials.