Randomized Controlled Trial of Pulpotomy in Primary Molars using MTA and Formocresol Compared to 3Mixtatin: A Novel Biomaterial.

OBJECTIVE: This study was conducted to compare the efficacy of 3Mixtatin (a combination of simvastatin and 3Mix antibiotic) with MTA and Formocresol for the pulpotomy of primary molars.

STUDY DESIGN: 114 children aged 3-6 years old with 150 primary molars were randomly allocated to three groups. MTA, Formocresol or 3Mixtatin were used for Pulpotomies. Hard setting zinc oxide eugenol was used to cover these materials. The teeth were restored with amalgam. Blinded radiographic and clinical examinations were conducted at 6, 12 and 24 months after treatment for the presence of pain, tenderness to palpation and percussion, sinus tract, swelling, presence of internal or external root resorption, inter-radicular radiolucency, and periapical lesion.

RESULTS: 122 teeth were available for 24-month follow-up study. The overall success rate was 78.9% for FC, 90.5% for 3Mixtatin and 88.1% for MTA group. There was no significant difference in overall success rate among the groups after 24-month follow-up (X2 =2.43, df = 2, P =0.27).

CONCLUSION: Our findings demonstrated remarkable results of 3Mixtatin in pulpotomy of primary teeth at the 24-month follow-up. Therefore, 3Mixtatin may be considered as an effective material in pulpotomy of primary teeth because of its successful results.