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IRCT20220426054664N1 IRCT 2022-05-31 Ahvaz University of Medical Sciences Coldceramic in primary Tooth Pulpotomy Evaluation and comparison of the effectiveness of mineral trioxide aggregate and cold ceramic in the success of primary molars pulpotomy: a clinical and radiographic study 2022-06-10 anticipated 42 Complete https://irct.ir/trial/63389 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Participants enter the study with their consent but do not know each tooth with which material was pulpotomized. The clinical caregiver treats primary pulpotomy but is unaware of the type and purpose of the study. Evaluators evaluate the clinical outcome and radiographs of treated teeth. They know the purpose of the study , but they do not know the type of material used for each pulpotomy treatment and group assignment. The person responsible for collecting the data is also unaware of the type of intervention and the type of substance used to treat the pulpotomy and to assign groups. Data analysts are aware of the type of intervention and group allocation. 4 pulpotomy. Intervention 1: Intervention group: Treatment of primary molar pulpotomy with cold ceramic , which is made in Iran and contains compounds of calcium oxide, silicon acid, these compounds are 93% of its components. Other components include MgO, MnO, Fe2O3, Na2O, K2O and TiO2. (First, anesthesia is performed in a child who is eligible for the study, and then tooth decay is removed and accessed, and cervical molar pulpotomy is performed and placed on wet cotton pulp for five minutes for homeostasis, then wet cotton. It is removed and the cold-ceramic powder is mixed with sterile serum in a ratio of 1: 1. When the paste is formed, it is placed on a pulp that has already been homeostasized, and glass ionomer light is placed on it and cured for 40 seconds, and finally the metal is coated. It is used as a permanent repair. Intervention 2: Control group: Treatment of primary molar pulpotomy with mineral trioxide aggregate, Made in Iran and contains compounds of tricalcium silicate, dicalcium silicate, tricalcium aluminate, tetracalcium aluminophyte, calcium sulfate and bismuth oxide. (First, anesthesia is performed in a child who is eligible for the study, and then tooth decay is removed and accessed, and cervical molar pulpotomy is performed and placed on wet cotton pulp for five minutes for homeostasis, then wet cotton. It is removed and the mineral trioxide aggregate powder is mixed with sterile serum in a ratio of 1: 1. When the paste is formed, it is placed on a pulp that has already been homeostasized, and glass ionomer light is placed on it and cured for 40 seconds, and finally the metal is coated. It is used as a permanent repair. Yes - There is a plan to make this available What will be shared: Evaluation and Comparison of Mineral Trioxide Aggregate and coldceramic in Primary Tooth Pulpotomy: Clinical and Radiographic Study When: Start the access period at the same time as printing the results To whom: for everyone Conditions: کو Where to obtain: bitarasteh992@gmail.com How to obtain: Send the request via email and receive a response within a month Comments:
public Bita Rasteh
No.14, damavand 7 building, Esfahan, Dey street
Ahwaz Iran (Islamic Republic of) 6381944814 +98 61 4352 4848 bitarasteh99@gmail.com Ahvaz University of Medical Sciences scientific Bita Rasteh
No.14, damavand 7 building, Esfahan, Dey street
Ahvaz Iran (Islamic Republic of) 63819448114 +98 61 4352 4848 bitarasteh@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) General and mental health of the child Lack of clinical adverse symptoms in the target tooth such as spontaneous pain or nocturnal pain, swelling of pulpal origin, pathological sagging, fistula Lack of adverse radiographic signs of the desired tooth such as internal root resorption, external root resorption and periapical or furca area 4 years 9 years Both Failure to refer the patient for 3 and 6 month follow-up Having an underlying disease Treatment - Drugs Treatment - Drugs Intervention group: Treatment of primary molar pulpotomy with cold ceramic , which is made in Iran and contains compounds of calcium oxide, silicon acid, these compounds are 93% of its components. Other components include MgO, MnO, Fe2O3, Na2O, K2O and TiO2. (First, anesthesia is performed in a child who is eligible for the study, and then tooth decay is removed and accessed, and cervical molar pulpotomy is performed and placed on wet cotton pulp for five minutes for homeostasis, then wet cotton. It is removed and the cold-ceramic powder is mixed with sterile serum in a ratio of 1: 1. When the paste is formed, it is placed on a pulp that has already been homeostasized, and glass ionomer light is placed on it and cured for 40 seconds, and finally the metal is coated. It is used as a permanent repair Control group: Treatment of primary molar pulpotomy with mineral trioxide aggregate, Made in Iran and contains compounds of tricalcium silicate, dicalcium silicate, tricalcium aluminate, tetracalcium aluminophyte, calcium sulfate and bismuth oxide. (First, anesthesia is performed in a child who is eligible for the study, and then tooth decay is removed and accessed, and cervical molar pulpotomy is performed and placed on wet cotton pulp for five minutes for homeostasis, then wet cotton. It is removed and the mineral trioxide aggregate powder is mixed with sterile serum in a ratio of 1: 1. When the paste is formed, it is placed on a pulp that has already been homeostasized, and glass ionomer light is placed on it and cured for 40 seconds, and finally the metal is coated. It is used as a permanent repair. Success of pulpotomy treatment. Timepoint: Follow-up 3 and 6 months after treatment. Method of measurement: Radiographs and clinical examination. Ahvaz University of Medical Sciences Approved 2022-01-01 Ethics committee of Ahwaz University of Medical Sciences No:14، Damavand7 building، Esfahan، Dey Street Ahwaz Khouzestan Iran (Islamic Republic of)