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IRCT20221017056214N1 IRCT 2022-11-02 Rasht University of Medical Sciences Investigating the effectiveness of mouthwash containing green tea extract and pomegranate peel, with and without zinc, compared to 0.12% chlorhexidine mouthwash on gingivitis in patients with gingivitis or mild chronic periodontitis: a double-blind randomized clinical trial CHX MW Investigating the effectiveness of mouthwash containing green tea extract and pomegranate peel, with and without zinc, compared to 0.12% chlorhexidine mouthwash on gingivitis in patients with gingivitis or mild chronic periodontitis: a double-blind randomized clinical trial 2022-08-01 anticipated 105 Complete https://irct.ir/trial/66381 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: So far, no study examines the synergistic effect of these two effective ingredients of green and pomegranate tea in control and improvement of periodontal diseases. Also, in previous studies, the effectiveness of zinc as a potent antioxidant has not been addressed to control the periodontal diseases, hence, we had an anti-inflammatory effect of mouthwash containing green tea extract and mouthwashes containing green tea extract_ zinc in We compared the prevention and improvement of periodontal diseases, Randomization description: Random allocation was based on 6 random blocks, whose sequence list was determined by Random Allocation Software and placed in three groups, Blinding description: Allocation concealment method was used in order to avoid the selection bias error (Information Bias). In this way, the number 1 to 35 was written on each envelope. In each envelope, based on the random numbers obtained, one of Three letters B, A and C were written and finally 35 envelopes were given to the second researcher. After the initial measurement of the indicators, the second researcher gave the corresponding mouthwash to the patients based on the number of patients written on the envelope and the intervention written inside the envelope. And they explained to the patients how to use it.In this study, researchers were blinded. In this way, the mouthwashes were packed in white opac bottles of the same size, so that the bottles cannot be distinguished from each other in terms of appearance. Only on the bottle of one of the three letters B, A and C, the pharmacist producing the mouthwashes was asked to write the content of each mouthwash in a closed letter and this letter should not be opened until the end of the study. Patients were not blinded in this study. For concealment, this list was kept in a sealed envelope in the research center or in the dental clinic office. 3 Mild chronic gingivitis or periodontitis. Intervention 1: Intervention group: Intervention group: patients in a questionnaire based on the block sequence list, in one of groups A (mouthwash containing pomegranate peel extract and green tea, with zinc), B (mouthwash containing pomegranate peel extract and green tea, without zinc) and C ( chlorhexidine mouthwash 0.12%) and received the corresponding mouthwash. Group A was the intervention; The people of this group were given green tea extract - pomegranate peel - zinc mouthwash. Group B was the same as the second intervention group, this group was given green tea extract-pomegranate skin mouthwash. Intervention 2: Intervention group: group C (the third group), which is the control group, was given 0.12% chlorhexidine. All patients were asked to use the given mouthwash (green tea extract-pomegranate peel-zinc mouthwash for group A, green tea extract extract-pomegranate peel mouthwash for group B and chlorhexidine 0.12% for group C) twice a day for two weeks. (after brushing teeth) use 10 ml of mouthwash each time. and if using mouthwash, record and report its consumption as follows. 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 The final decision is not yet known
public Bardia vadiati
Academic Complex of Gilan University of Medical Sciences, Department of Periodontology,In front of Khazar
Rasht Iran (Islamic Republic of) 4194173774 0981333486406 Dr.bardia_vad@yahoo.com Rasht University of Medical Sciences scientific Bardia vadiati
Academic Complex of Gilan University of Medical Sciences, Department of Periodontology,In front of Khazar and Padideh restaurants,2 km to Fuman,Saravan belt,The end of the Lacan road,gas field
Rasht Iran (Islamic Republic of) 4194173774 0981333486407 Dr.bardia_vad@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Having at least 20 natural teeth Suffering from gingivitis or mild chronic periodontitis Loss of clinical connections less than or equal to 2 mm Probe depth less than or equal to 3 mm will be included in the study no limit no limit Both Allergic reaction to pomegranate Systemic diseases such as diabetes mellitus Pregnant and lactating women Cigarette or tobacco user Taking antibiotics or non-steroidal anti-inflammatory drugs in the 6 months before the study History of receiving periodontal interventions in the 6 months before the study ,K05.10 Chronic gingivitis, plaque induced Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: patients in a questionnaire based on the block sequence list, in one of groups A (mouthwash containing pomegranate peel extract and green tea, with zinc), B (mouthwash containing pomegranate peel extract and green tea, without zinc) and C ( chlorhexidine mouthwash 0.12%) and received the corresponding mouthwash. Group A was the intervention; The people of this group were given green tea extract - pomegranate peel - zinc mouthwash. Group B was the same as the second intervention group, this group was given green tea extract-pomegranate skin mouthwash. Intervention group: group C (the third group), which is the control group, was given 0.12% chlorhexidine. All patients were asked to use the given mouthwash (green tea extract-pomegranate peel-zinc mouthwash for group A, green tea extract extract-pomegranate peel mouthwash for group B and chlorhexidine 0.12% for group C) twice a day for two weeks. (after brushing teeth) use 10 ml of mouthwash each time. and if using mouthwash, record and report its consumption as follows. Measuring the PBI index of the gingival groove is probed by using the Michigan O probe with Williams marking, in walking mode. 30 seconds after probing the gingival groove, the presence or absence of bleeding in 3 points on the buccal surface (mesiobuccal, midbuccal and distobuccal) and 3 points on the lingual surface (mesiolingual, midlingual and distolingual) will be checked and recorded. The number of bleeding areas will be calculated and this index will be reported as the percentage of bleeding dental surfaces compared to the total dental surfaces.MGI index of inflammation, color change and gum contour change will be checked in 6 points around all teeth. 3 points on the buccal level (mesiobuccal, midbuccal and distobuccal) and 3 points on the lingual level (mesiolingual, midlingual and distolingual) are evaluated and each one will be given a score from 0 to 4. So that score 0 is without inflammation; score 1, the presence of mild inflammation with a slight change in color and contour in parts of the gum; score 2, the presence of mild inflammation in the entire gum; Score 3 means moderate inflammation and score 4 means severe inflammation. The average of the obtained numbers will be calculated and reported. To measure the PI index, patients are asked to chew Fushin tablets for 60 seconds and then rinse their mouths. Stained surfaces will be considered as positive surfaces. Unpainted surfaces are considered as negative surfaces. Staining or not staining will be evaluated at 4 points including midbuccal, mesial papillae, midlingual and distal papillae. This index is reported as the percentage of stained areas compared to the total tooth surfaces. Timepoint: Indicators are measured 2 weeks after using the mouthwash. Method of measurement: MGI index and PI index are clinically evaluated based on the indices. 30 After exploring the gingival groove, the presence or absence of presence is checked. Paid in person. Approved 2022-07-31 Ethics Committee of Gilan University of Medical Sciences Sardar Soleimani's dormitory,Kargar alley 1,Lacan Blvd Rasht Guilan Iran (Islamic Republic of)