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IRCT20220223054108N2 IRCT 2023-06-10 Gorgan University of Medical Sciences Effect of nanocurcumin and chlorhexidine mouthwash on level of prostaglandin E2 Evaluation of nanocurcumin and chlorhexidine mouthwash effect on the prostaglandin E2 biomarker concentration in gingival crevicular fluid of fixed orthodontic patients 2023-06-20 anticipated 88 Complete https://irct.ir/trial/69750 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: Eligible subjects will be assigned to the nanocurcumin and chlorhexidine mouthwash groups, the nanocurcumin only and chlorhexidine only, and the control group using the random block method. We first create a random sequence of 11 eight-block random blocks. Random numbers were generated in R software and In each block, each letter A, B, C, D is repeated twice. ABCDACDB, CADBACBD, DACBBCAD, ABBCDACD, CADBACDB,… In the desired sequence, there will be 22 letters from each letter A, B, C, D. According to the above block, 88 envelopes will be prepared, and in each envelope, the letters A, B, C, D will be placed and will be numbered from 1 to 88. The person delivering the envelopes to the patients does not know what is inside. This intervention is a two-sided blind type where the researcher knows the type of mouthwash, but the patients do not know about it. A random sequence is produced by a statistics and methodology consultant who does not have access to patients. Patients who received the letter A in the nanocurcumin mouthwash group, patients who received the letter B in the chlorhexidine group, and patients who received the letter C in the nanocurcumin and chlorhexidine group patients who received the letter D in the control group will be placed, Blinding description: In this study, only the researcher knows the type of mouthwash prescribed for each patient. Nurses and patients do not have any information about the type of mouthwash to use and only receive instructions on how to use it. The random sequence generation is done by the statistics and methodology consultant, but he does not have access to the patients and is in the category of blinded subjects. 2-3 teeth shifting. Intervention 1: Intervention group: In this group, patients are asked to mix 20 drops of nanocurcumin mouthwash with 10 cc of water and use for 30 seconds as a mouthwash twice a day for two weeks after brushing. Dr. Khori Danesh Bonyan Pharmaceutical Company makes Nanocurcumin mouthwash with a concentration of 2% with confirmation code No. 184620 of Golestan University of Medical Sciences. This mouthwash is prepared with the chemical composition C21H20O6 with over 70% purity degree and a molecular weight of 368 from Sigma & Aldrich Co. Intervention 2: Intervention group: In this group, patients are asked to mix 20 drops of 0.2% chlorhexidine mouthwash with 10 cc of water and use for 30 seconds according to the written instruction on the mouthwash twice a day for two weeks after brushing. Intervention 3: Intervention group: In this group, patients are asked to mix 20 drops of nanocurcumin plus chlorhexidine combined mouthwash with 10 cc of water and use for 30 seconds as a mouthwash twice a day for two weeks after brushing. Intervention 4: Control group: In this group, patients are asked to use 10 cc of 0.9% normal saline as a mouthwash for 30 seconds as a mouthwash twice a day for two weeks after brushing. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Aliakbar Naghavialhosseini
Shahryar 5 St., Shahryar Town
Gorgan Iran (Islamic Republic of) 4913983635 +98 17 3262 7823 a.a.nagavi@gmail.com Gorgan University of Medical Sciences scientific Aliakbar Naghavialhosseini
Shahryar 5 St., Shahryar Town
Gorgan Iran (Islamic Republic of) 4913983635 +98 17 3262 7823 a.a.nagavi@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Agreement to participation in the study 15 to 35 years old Passed at least 2 mounts after fixed orthodontics treatment Negative for hypersensitivity to Curcumin and/or chlorhexidine 15 years 35 years Both The presence of any ulcer or intraoral infection Severe gingival inflammation or periodontal pocket Systemic disease Pregnant and lactating mothers Antibiotics usage in a month before the study Fluoride therapy in the last 6 months Tobacco usage Corticosteroids and NSAIDs usage Z51.8 Encounter for other specified aftercare Prevention Prevention Prevention N/A Intervention group: In this group, patients are asked to mix 20 drops of nanocurcumin mouthwash with 10 cc of water and use for 30 seconds as a mouthwash twice a day for two weeks after brushing. Dr. Khori Danesh Bonyan Pharmaceutical Company makes Nanocurcumin mouthwash with a concentration of 2% with confirmation code No. 184620 of Golestan University of Medical Sciences. This mouthwash is prepared with the chemical composition C21H20O6 with over 70% purity degree and a molecular weight of 368 from Sigma & Aldrich Co. Intervention group: In this group, patients are asked to mix 20 drops of 0.2% chlorhexidine mouthwash with 10 cc of water and use for 30 seconds according to the written instruction on the mouthwash twice a day for two weeks after brushing. Intervention group: In this group, patients are asked to mix 20 drops of nanocurcumin plus chlorhexidine combined mouthwash with 10 cc of water and use for 30 seconds as a mouthwash twice a day for two weeks after brushing. Control group: In this group, patients are asked to use 10 cc of 0.9% normal saline as a mouthwash for 30 seconds as a mouthwash twice a day for two weeks after brushing. Prostaglandin E2 before and two weeks later in all studied groups. Timepoint: Measurement of prostaglandin E2 at the study's baseline (before starting treatment) and two weeks after consuming the prescribed mouthwashes for each group. Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA test). Patients' perception of taste in the group of patients using prescribed mouthwashes. Timepoint: The seventh day after using the prescribed mouthwashes. Method of measurement: Individually asking each of the participants about the taste of the prescribed mouthwash based on a questionnaire to check the quality of mouthwash. Gorgan University of Medical Sciences Approved 2023-03-05 Research Ethics Committees of Golestan University of Medical Sciences 5th Shahryar Gorgan Golestan Iran (Islamic Republic of)