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IRCT20200120046197N1 IRCT 2021-02-26 Shiraz University of Medical Sciences Effect of Metformin Combination with Double Antibiotic Paste (DAP) in Tooth Pulp Regeneration Comparison of the Effect of Double Antibiotic Paste Alone or in Combination with Metformin on Regeneration of Non-Vital Immature Teeth: A Pilot Clinical Study 2021-01-20 anticipated 24 Complete https://irct.ir/trial/45140 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization Method was used for the Patient's Allocation into two groups with a 1:1 Ratio by RANDOM.ORG Software. Participants were divided into two Groups of Double Antibiotic Paste Revascularization techniques with and without Metformin, Blinding description: The Double Antibiotic pastes with the same Color, Consistency, and Volume are delivered in the same Container to the Practitioner. Participants ( patients) have no idea about the materials that were used for them. Observers have no Idea about the materials which are used for the Patients. The Researcher is the only one who knows about suggested Materials which is used for each Patient and leads the Research. 2-3 Tooth Pulp Necrosis. Intervention 1: Control group: the tooth is anesthetized, isolated, and accessed. After determining the working length, the canals should be copiously irrigated with NAOCL 1.5%followed by 17% EDTA. Canals were dried with sterile paper points and double antibiotic paste (DAP) as a mixture of Ciprofloxacin 500 mg (Tolidaru Co.) and Metronidazole 250mg (Kosar Co.) at the concentration of 1mg/ml is placed into the canals for 3-4weeks. In the second appointment, canals should be irrigated with 17%EDTA, and after the creation of bleeding with a No.25 file, on top of the coagulum, about 3 mm of MTA is then placed. Intervention 2: Intervention group: the tooth is anesthetized, isolated, and accessed. After determining the working length, the canals should be copiously irrigated with NAOCL 1.5%followed by 17% EDTA. Canals were dried with sterile paper points and double antibiotic paste (DAP) as a mixture of Ciprofloxacin 500 mg (Tolidaru Co.) and Metronidazole 250mg (Kosar Co.) Adding Metformin 500mg (Abidi Co.) with the same volume of antibiotics at the concentration of 1mg/ml is placed into the canals for 3-4weeks. In the second appointment, canals should be irrigated with 17%EDTA, and after the creation of bleeding with No.25 file, on top of the coagulum, about 3 mm of MTA is then placed. Yes - There is a plan to make this available What will be shared: The result of study consist of clinical and radiographic findings of participants due to the kind of materials which was used When: 6 months after publishing To whom: No limit Conditions: With referencing of the article Where to obtain: Corresponding author How to obtain: Written request by email for corresponding author. One month after the permission of all authors Comments:
public Dr. Fariborz Moazami
Shiraz dental School, Ghasrdasht St.
Shiraz Iran (Islamic Republic of) ۷۱۹۵۶-۱۵۸۷۸ +98 71 3626 3193 fmoazzami@sums.ac.ir Shiraz University of Medical Sciences scientific Dr, Fariborz Moazmi
Shiraz dental school , Ghasrdasht St.
Shiraz Iran (Islamic Republic of) 71956-15878 +98 71 3626 3194 fmoazzami@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Non- Vital Permanent Teeth with Open Apex(File size equal or more than 60) With or without Radiographic Radiolucency Negative Response to Pulp Vitality Test Restorable Tooth No Systemic Conditions 7 years 11 years Both Severe periodontal disease, Internal and external root resorption - - Treatment - Drugs Treatment - Drugs Control group: the tooth is anesthetized, isolated, and accessed. After determining the working length, the canals should be copiously irrigated with NAOCL 1.5%followed by 17% EDTA. Canals were dried with sterile paper points and double antibiotic paste (DAP) as a mixture of Ciprofloxacin 500 mg (Tolidaru Co.) and Metronidazole 250mg (Kosar Co.) at the concentration of 1mg/ml is placed into the canals for 3-4weeks. In the second appointment, canals should be irrigated with 17%EDTA, and after the creation of bleeding with a No.25 file, on top of the coagulum, about 3 mm of MTA is then placed. Intervention group: the tooth is anesthetized, isolated, and accessed. After determining the working length, the canals should be copiously irrigated with NAOCL 1.5%followed by 17% EDTA. Canals were dried with sterile paper points and double antibiotic paste (DAP) as a mixture of Ciprofloxacin 500 mg (Tolidaru Co.) and Metronidazole 250mg (Kosar Co.) Adding Metformin 500mg (Abidi Co.) with the same volume of antibiotics at the concentration of 1mg/ml is placed into the canals for 3-4weeks. In the second appointment, canals should be irrigated with 17%EDTA, and after the creation of bleeding with No.25 file, on top of the coagulum, about 3 mm of MTA is then placed. Pulp revitalization. Timepoint: Before intervention and patient follow up for 3 and 12 months after intervention. Method of measurement: Clinical And Radiographic Assessment. Changes in diameter of root dentin with the regenerated tissues. Timepoint: Before intervention and patient follow up for 3 and 12 months after intervention. Method of measurement: Clinical And Radiographic Assessment. Changes the length of root with the regenerated tissues. Timepoint: Before intervention and patient follow up for 3 and 12 months after intervention. Method of measurement: Clinical And Radiographic Assessment. Shiraz University of Medical Sciences Approved 2020-01-05 Ethics committee of Shiraz University of Medical Sciences Shiraz Dental School , GHasrdasht St..reet Shiraz Fars Iran (Islamic Republic of)