Comparison of gray mineral trioxide aggregate and diluted formocresol in pulpotomized primary molars: a 6- to 24-month observation.

Purpose: The purpose of this multisite, multioperator, prospective, randomized, controlled clinical trial was to evaluate 2-year outcomes of diluted formocresol (DFC) compared to gray mineral trioxide aggregate (GMTA) as pulpotomy medicaments.

Methods: Following the standard pulpotomy procedure, the pulp stumps of 252 primary molars in 168 healthy children were randomly covered with GMTA or DFC. Pulp chambers were filled with Intermediate Restorative Material (IRM(®)) and teeth were restored with stainless steel crowns. At each follow-up appointment, the clinical status of the treated tooth was assessed and radiographs were taken. A total of 694 clinical and radiographic evaluations were analyzed.

Results: Gender, study site, arch type, and tooth type did not influence treatment outcome. At the combined 6- to 24-month follow-up, clinical success in the DFC group was no different than for the GMTA group. Radiographically, a significantly lower success rate was found in the DFC group vs the MTA group at all time points (P<.01). Dentin bridge formation was observed at a significantly higher frequency among the GMTA group (P<.01), while internal root resorption was observed at a higher frequency in the DFC group (P<.01).

Conclusion: At the combined 6- to 24-month follow-up, gray mineral trioxide aggregate demonstrated significantly better radiographic outcomes vs diluted formocresol as pulpotomy medicaments.