Efficacy of three different pulpotomy agents in primary molars – A randomised control trial
International Endodontic JournalAccepted Article (Accepted, unedited articles published online and citable. The final edited and typeset version of record will appear in future
To compare the clinical and radiographic efficacy of Biodentine™, ProRoot® White Mineral Trioxide Aggregate (WMTA) and Tempophore™ as pulpotomy medicaments in the treatment of carious primary molars.
A parallel design, randomised controlled trial was developed. Patients above three years of age with carious primary teeth with vital pulps without spontaneous pain or history of swelling were included. Fifty eight patients (82 teeth) with a mean age of 4.79 ± 1.23 years were included. The teeth were randomised, blinded and allocated to one of the three groups (Biodentine™, ProRoot® WMTA or Tempophore™) for pulpotomy treatment. All teeth were followed up clinically and radiographically (after 6, 12 and 18 months) by two blinded calibrated investigators. A generalised estimating equation (GEE), Wald chi-square test and an intention to treat analysis (ITT) with ′last carried forward′ approach was performed using Statistical Package for Social Sciences v 21.0 (IBM Corp., Armonk, NK, USA).
Forty six patients and 69 teeth were available for follow up after 18 months. Clinical success (radiographic success in parenthesis) was 95.24% (94.4%), 100% (90.9%) and 95.65% (82.4%) in the Biodentine™, ProRoot® MTA and Tempophore™ groups respectively, but the difference was not significant. Pulp canal obliteration was significantly different among the experimental groups as the Biodentine™ group exhibited significantly more pulp canal obliteration when compared to the ProRoot® MTA group at 6 months (p = 0.008) and 18 months (p = 0.003).
After 18 months follow up, there was no significant difference between Biodentine™ in comparison to ProRoot® WMTA or Tempophore™.