]>
IRCT20220223054108N1 IRCT 2022-04-03 Gorgan University of Medical Sciences Effects of nanocurcumin and chlorhexidine mouthwash on levels of interleukin 1 and 6 Comparison of nanocurcumin and chlorhexidine mouthwash on levels of gingival crevicular fluid interleukin 1 and 6 in patients undergoing fixed orthodontics treatment 2022-04-20 anticipated 88 Complete https://irct.ir/trial/62597 interventional Randomization: Randomized, Blinding: Single 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. 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. A random sequence is produced by a statistics and methodology consultant who does not have access to patients, and only he knows what is in each number. Patients who received the letter A in the nanocurcumin and chlorhexidine mouthwash group, patients who received the letter B in the nanocurcumin group, and patients who received the letter C in the chlorhexidine group patients who received the letter D in the control group will be placed, Blinding description: A random sequence is produced by a statistics and methodology consultant who does not have access to patients, and only he knows what is in each number. 2-3 teeth shifting. Intervention 1: Intervention group 1: 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 2: In this group, patients are asked to mix 20 drops of 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 3: In this group, patients are asked to mix 20 drops of nano-curcumin 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 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 current study 15 to 35 years old Good periodontal health Systemically healthy Passed at least 2 mounts after fixed orthodontics treatment Negative for hypersensitivity to Curcumin and/or chlorhexidine. 15 years 35 years Both Tobacco usage Antibiotics, Aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) usage during the past one month Pregnant and lactating mothers Prevention Prevention Prevention N/A Intervention group 1: 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 2: In this group, patients are asked to mix 20 drops of 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 3: In this group, patients are asked to mix 20 drops of nano-curcumin 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 normal saline as a mouthwash for 30 seconds as a mouthwash twice a day for two weeks after brushing. Interleukin 1 & 6 before and two weeks later in the patients consuming curcumin mouthwash. Timepoint: Measurement of Interleukin1 & 6 in the study baseline (before treatment beginning) and 2 weeks after starting fixed orthodontic treatment. Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA test). Interleukin 1 & 6 before and two weeks later in the group of patients consuming chlorhexidine mouthwash. Timepoint: Measurement of Interleukin 1 & 6 in the study baseline (before treatment beginning) and 2 weeks after starting fixed orthodontic treatment. Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA test). Interleukin 1 & 6 before and two weeks after in the group consuming curcumin + chlorhexidine mouthwash. Timepoint: Measurement of Interleukin 1 & 6 in the study baseline (before treatment beginning) and 2 weeks after starting fixed orthodontic treatment. Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA test). Interleukin 1 & 6 before and two weeks after in the group of patients consuming normal saline mouthwash. Timepoint: Measurement of Interleukin 1 & 6 in the study baseline (before treatment beginning) and 2 weeks after starting fixed orthodontic treatment. Method of measurement: Enzyme-linked Immunosorbent Assay (ELISA test). Comparison of differences in Interleukin 1 & 6 concentration before and two weeks later between two groups of patients using mouthwash containing curcumin and chlorhexidine. Timepoint: before treatment and 2 weeks after starting fixed orthodontic treatment. Method of measurement: ELISA (enzyme-linked immunosorbent assay). Comparison of difference in Interleukin1 & 6 concentration before and two weeks later between two groups of patients using mouthwash containing curcumin and curcumin + chlorhexidine. Timepoint: before treatment and 2 weeks after starting fixed orthodontic treatment. Method of measurement: ELISA (enzyme-linked immunosorbent assay). Comparison of differences in Interleukin1 & 6 concentration before and 2 weeks later between 2 groups of patients using mouthwash containing curcumin and normal saline. Timepoint: before treatment and 2 weeks after starting fixed orthodontic treatment. Method of measurement: ELISA (enzyme-linked immunosorbent assay). Comparison of differences in Interleukin1 & 6 concentration before and 2 weeks later between 2 groups of patients using mouthwash containing chlorhexidine and curcumin+ chlorhexidine. Timepoint: before treatment and 2 weeks after starting fixed orthodontic treatment. Method of measurement: ELISA (enzyme-linked immunosorbent assay). Comparison of differences in Interleukin1 & 6 concentration before and 2 weeks later between 2 groups of patients using mouthwash containing chlorhexidine and normal saline. Timepoint: before treatment and 2 weeks after starting fixed orthodontic treatment. Method of measurement: ELISA (enzyme-linked immunosorbent assay). Gorgan University of Medical Sciences Approved 2022-01-30 Research Ethics Committees of Golestan University of Medical Sciences Shahryar Gorgan Golestan Iran (Islamic Republic of)