PURPOSE: The purpose of this multisite, multioperator, prospective, randomized, controlled clinical trial was to evaluate the 6-month outcomes of diluted formocresol (DFC) compared to gray mineral trioxide aggregate (GMTA) as pulpotomy medicament. METHODS: Determined by a power analysis, 252 molars of 152 children were recruited. The teeth were randomly assigned to receive GMTA or DFC. At the 6-month follow-up, 118 children with 203 treated teeth were evaluated. RESULTS: Four blinded and calibrated evaluators scored each radiograph for pathologies. Clinical success was similar for DFC (97%) and GMTA (100%), (P<.09). Radiographic success differed significantly (P<.04) for DFC (86%) and GMTA (95%). Pulp canal obliteration was radiographically observed in 25% of the DFC group and in 37% of the GMTA group (P=.07). Dentin bridging was observed in 22% of the GMTA group but was not found in the DFC group (P<.01). CONCLUSION: Teeth treated with GMTA showed more favorable radiographic outcomes than DFC at 6 months post-treatment.
RCT Entities:
PURPOSE: The purpose of this multisite, multioperator, prospective, randomized, controlled clinical trial was to evaluate the 6-month outcomes of diluted formocresol (DFC) compared to gray mineral trioxide aggregate (GMTA) as pulpotomy medicament. METHODS: Determined by a power analysis, 252 molars of 152 children were recruited. The teeth were randomly assigned to receive GMTA or DFC. At the 6-month follow-up, 118 children with 203 treated teeth were evaluated. RESULTS: Four blinded and calibrated evaluators scored each radiograph for pathologies. Clinical success was similar for DFC (97%) and GMTA (100%), (P<.09). Radiographic success differed significantly (P<.04) for DFC (86%) and GMTA (95%). Pulp canal obliteration was radiographically observed in 25% of the DFC group and in 37% of the GMTA group (P=.07). Dentin bridging was observed in 22% of the GMTA group but was not found in the DFC group (P<.01). CONCLUSION: Teeth treated with GMTA showed more favorable radiographic outcomes than DFC at 6 months post-treatment.
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