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IRCT20180521039763N2 IRCT 2019-05-09 Kerman University of Medical Sciences Comparison of clinical and radiographic success rate of pulpotomy in primary molars using Biodentine, Endo repair and Formocresol: A double blind randomized clinical trial Comparison of clinical and radiographic success rate of pulpotomy in primary molars using Biodentine, Endo repair and Formocresol: A double blind randomized clinical trial 2018-10-22 anticipated 105 Complete https://irct.ir/trial/38766 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Given that external factors, such as age and/or gender, are not affected by the outcome (clinical and radiographic success rate) there is no need for advanced randomization such as minimization. In addition, a therapist will perform all pulpotomies to eliminate the role of the therapist.Therefore, individuals in this study, using simple randomization and random numbers are entered into three groups of study, Blinding description: Follow up evaluations are carried out by two researchers who are not aware of the type of treatment and they will comment on radiographic criteria. The statistician is not aware of the type of treatment. N/A Pulpitis. Intervention 1: Control group: Cotton pellet impregnated with formocresol (sultan, USA) is placed on the pulp for 5 minutes. Intervention 2: Intervention group: 1: After pulp tissue homeostasis, the Biodentine substance (Septodont, Saint-Maur-des-Fosses, France) is placed into the pulp chamber according to the manufacturer's instructions. 2: After the pulp tissue homeostasis, the material Endo repair (HOFFMANN'S, Germany) is combined according to the manufacturer's instructions and will be placed in the pulp chamber. Yes - There is a plan to make this available What will be shared: Only a portion of the data is shared, such as the original outcome information. When: Start the access period, 6 months after printing the results. To whom: Only for researchers working in academic and scientific institutions. Conditions: For researchers Where to obtain: fznjalali@gmail.com How to obtain: 1 month Comments:
public Farzane Jalali
Shafa Ave
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 fznjalali@gmail.com Kerman University of Medical Sciences scientific Farzane Jalali
Shafa Ave
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 fznjalali@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) Pulp exposure due to caries No pathologic mobility No history of spontaneous pain No sinus tracts, abscess or swelling Restorable teeth with ssc Hemostasis could be easily achievable No internal or pathologic external root resorption No interradicular or periapical radiolucency 3 years 10 years Both Treatment - Drugs Treatment - Drugs Control group: Cotton pellet impregnated with formocresol (sultan, USA) is placed on the pulp for 5 minutes Intervention group: 1: After pulp tissue homeostasis, the Biodentine substance (Septodont, Saint-Maur-des-Fosses, France) is placed into the pulp chamber according to the manufacturer's instructions. 2: After the pulp tissue homeostasis, the material Endo repair (HOFFMANN'S, Germany) is combined according to the manufacturer's instructions and will be placed in the pulp chamber. Mutation and cytogenetic formocresol. Timepoint: 0 , 6 and 12 months later. Method of measurement: Through clinical and radiographic evaluation and questionnaire. Kerman University of Medical Sciences Approved 2018-10-07 Ethics committee of Kerman University of Medical Sciences Shafa Ave Kerman Kerman Iran (Islamic Republic of)