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IRCT20220611055141N1 IRCT 2022-08-16 Arak University of Medical Sciences The effect of chitosan mouthwash on plaque and gingival indices in patients with fix orthodontic Comparison of the effect of chitosan mouthwash and chitosan-free mouthwash on plaque and gingival indices of fixed orthodontic patients 2022-09-06 anticipated 22 Complete https://irct.ir/trial/64173 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, block randomization method is used. For this purpose, using blocks of size 4 including AABB, ABAB, BBAA, etc. is used and selected. These blocks will be selected using a random number table, Blinding description: This study will be double-blind, in which the patients and the researcher, who is a dentist trained by periodontics specialist will be blind. In this way, patients and researchers in both mouthwash groups will not notice the difference between the mouthwashes due to the similar appearance of the mouthwash bottles. The result information is also provided by a dentist trained by a periodontics specialist who does not know which group the patient is in. 3 PD (Probe Depth); BOP (Probe on Bleeding); PI (Plaque Index); GI (Gingival Index). Intervention 1: Intervention group: Chitosan mouthwash (2 times a day) will be used. Patients should rinse 10cc of mouthwash for 60 seconds at a time and do not consume anything until 30 minutes later .Low molecular weight (75% <DD <85%, MW 107 kDa) and high (75% <DD, MW 624 kDa) chitosan produced by Sigma-Aldrich, St. Louis, USA, for the production of mouthwash will be. Chitosan mouthwash will be produced with 0.4% v / v dose and PH = 5. This compound will be composed of 0.5% (W / V) NaCl salt, 1% (W / V) of Arabic gum stabilizer and 5% (W / V) of Mannitol. After complete solution, food flavor and food coloring are added at a dose of 0.1% (V / V). Intervention 2: Control group: mouthwash without chitosan (2 times a day) will be used. Patients should rinse 10cc of the mouthwash for 60 seconds and not consume anything for 30 minutes after that. Chitosan-free mouthwash with PH=5 will be produced. This composition will be formed with 0.5% (W/V) NaCl salt, 1% (W/V) of Arabic gum stabilizer and 5% (W/V) of Mannitol. After the complete solution, food flavoring and food colors are added at a dose of 0.1% (V/V). Chitosan-free mouthwash is used as a placebo and contains the ingredients mentioned above with the same pH; It is prepared without the main ingredient, which is chitosan. This mouthwash is prepared from the same company from which the original mouthwash is purchased. The container containing the mouthwash and the witness will be similar in appearance so that patients do not notice the difference. 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 more information
public Amirmohammad Jafari
No. 5 , Shahid Aghaee Alley, Shahid Mahmoodi Ave , Shohada Ave
Varamin Iran (Islamic Republic of) 3371816671 +98 21 3624 1029 amirjafari7698@gmail.com Arak University of Medical Sciences scientific Amirmohammad Jafari
No. 5 , Shahid Aghaee Alley, Shahid Mahmoodi Ave , Shohada Ave
Varamin Iran (Islamic Republic of) 3371816671 +98 21 3624 1029 amirjafari7698@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) No dental caries No disease and periodontal surgery not used antibiotics in the last three months 18 years 35 years Both Infection in the last six months diabetes smoking Consumption of alcohol Pregnancy Cancer Taking medications that affect periodontal conditions Systemic conditions require antibiotic prophylaxis prior to periodontal examination Patients who have a history of fixed orthodontic treatment in the past or any dental treatment during the study Treatment - Drugs Placebo Intervention group: Chitosan mouthwash (2 times a day) will be used. Patients should rinse 10cc of mouthwash for 60 seconds at a time and do not consume anything until 30 minutes later .Low molecular weight (75% <DD <85%, MW 107 kDa) and high (75% <DD, MW 624 kDa) chitosan produced by Sigma-Aldrich, St. Louis, USA, for the production of mouthwash will be. Chitosan mouthwash will be produced with 0.4% v / v dose and PH = 5. This compound will be composed of 0.5% (W / V) NaCl salt, 1% (W / V) of Arabic gum stabilizer and 5% (W / V) of Mannitol. After complete solution, food flavor and food coloring are added at a dose of 0.1% (V / V). Control group: mouthwash without chitosan (2 times a day) will be used. Patients should rinse 10cc of the mouthwash for 60 seconds and not consume anything for 30 minutes after that. Chitosan-free mouthwash with PH=5 will be produced. This composition will be formed with 0.5% (W/V) NaCl salt, 1% (W/V) of Arabic gum stabilizer and 5% (W/V) of Mannitol. After the complete solution, food flavoring and food colors are added at a dose of 0.1% (V/V). Chitosan-free mouthwash is used as a placebo and contains the ingredients mentioned above with the same pH; It is prepared without the main ingredient, which is chitosan. This mouthwash is prepared from the same company from which the original mouthwash is purchased. The container containing the mouthwash and the witness will be similar in appearance so that patients do not notice the difference. Probe depth above 3 mm. Timepoint: Probe depth measurement at the beginning of the study and 30 days after using the mouthwash. Method of measurement: With a Michigan calibrated periodontal probe. Bleeding on probing. Timepoint: Measurement of bleeding during probing at the beginning of the study and 30 days after using the mouthwash. Method of measurement: With a Michigan calibrated periodontal probe. Gingival index. Timepoint: Measurement of gingival index at the beginning of the study and 30 days after using the mouthwash. Method of measurement: Observational. Plaque index. Timepoint: Measuring the plaque index at the beginning of the study and 30 days after using the mouthwash. Method of measurement: The degree of staining of dental plaque after using Fuchsin tablets. Arak University of Medical Sciences Approved 2022-05-15 Ethics Committee of Arak University of Medical Sciences Arak University of Medical Sciences, Payambar Azam Complex, Sardasht arak Markazi Iran (Islamic Republic of)