Clinical and Radiographic Evaluation of Biodentine Versus Formocresol in Vital Pulpotomy of Primary Molars: (A Randomized Control Clinical Trial)

Study design Randomized clinical trial, double blinded using split mouth technique. Study setting This study was carried out in Pediatric Dentistry Department-Faculty of Dentistry-Cairo University- Egypt.

Patients

Patients recruited for this study were selected according to the following criteria:

• Healthy children between 4 and 6 years of age with two matched bilateral deep carious primary mandibular first or second molars.
• No evident clinical symptoms of pulpal necrosis or pulp degeneration such as pain on percussion, spontaneous pain, history of swelling or presence of sinus tract.
• No pathologic or physiologic mobility.
• No radiographic evidence of internal and external resorption, pulp stone, and interradicular or periapical lesions (Preoperative radiograph).
• The remaining tooth structure would be restorable with a stainless steel crown.
• Bleeding time after amputation of the coronal pulp tissue was within normal limits (5 minutes).

Sample size calculation using sealedenvelop.com, (30) the online sample calculator, sample size was calculated assuming the null hypothesis that biodentine and formocresol have an average success rate of 95,99 % and 87.8 % respectively (26, 31,32,33). Thus planning a binary outcome non inferiority trial with a difference of 8.19 %, then 76 primary molars (38 per group) are required to be 90% sure that the upper limit of a one-sided 95% confidence interval will exclude a difference in favor of the standard group of more than 10% (34).