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IRCT20230305057627N1 IRCT 2023-04-17 Ahvaz University of Medical Sciences Comparison of the effectiveness of shallomin II and chlorhexidine mouthwashes in treating plaque induced gingivitis Comparison of the effectiveness of shallomin II and chlorhexidine mouthwashes in treating plaque induced gingivitis: A clinical trial and microbiologic study 2023-04-21 anticipated 36 Complete https://irct.ir/trial/69054 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study the randomization will be done using random numbers table. After consultation with the statistics specialist even numbers will be considered for the intervention group and odd numbers for control group. The researcher stays on one of the numbers then the right direction which predefined to move and the numbers will be registered, Blinding description: Shallomin mouthwash will be made with the taste and color of used chlorhexidine mouthwash. Both mouthwashes are put in the same bottles and coded (code 1 and 2). All coded bottles are placed in exactly the same packaging. The examiner will give each patient a package without knowing the meaning of each code and the type of bottle in each package, and after opening the package, the bottle code of each patient will be noted. During the study, the examiner and the patients will not know the type of mouthwash used. Meanwhile, patients are aware of participating in the study. 3 gingivitis. Intervention 1: Intervention group: 18 patients should use Shallomin II mouthwash twice a day for 2 weeks, each time at 5 cc for 30 seconds, and avoid eating and drinking for 30 to 45 minutes. The patient is also taught the correct method of brushing and hygiene education. Intervention 2: Intervention group: 18 patients should use 0.2% chlorhexidine mouthwash twice a day for 2 weeks, each time at 5 cc for 30 seconds, and avoid eating and drinking for 30 to 45 minutes. The patient is also taught the correct method of brushing and hygiene education. Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome, can be shared. When: Access starts 6 months after the results are published. To whom: Only for researcher working in academic and scientific institutions Conditions: There are no conditions and all colleagues can use all the data Where to obtain: Reza Kaviani Nezhad, Email adress: rezakv999@gmail.com How to obtain: Finally one week after requesting data or documentation Comments:
public Reza Kaviani Nezhad
Dental School, Dey Ave, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135715775 +98 61 3376 5825 rezakv999@gmail.com Ahvaz University of Medical Sciences scientific Neda Samie
Jundishapur Dental School, Dey Ave, Golestan Blvd
Ahvaz Iran (Islamic Republic of) 6135715775 +98 61 3376 5825 samie-n@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Systemically healthy The presence of more than 20 permanent teeth (except the third molar) Untreated gingivitis (probing depth less than equal to 3, no clinical attachment loss, no evidence of radiographic bone loss.) The percentage of areas with bleeding during probing should be more than 30% Not using antibiotics and anti-inflammatory drugs in the last three months No mouthwash has been used in the past month Do not use cigarettes or alcohol Do not have mental retardation Not during pregnancy or breastfeeding 18 years no limit Both The presence of any pathology in the oral mucosa Acute gingivitis K05.10 Chronic gingivitis, plaque induced Treatment - Drugs Treatment - Drugs Intervention group: 18 patients should use Shallomin II mouthwash twice a day for 2 weeks, each time at 5 cc for 30 seconds, and avoid eating and drinking for 30 to 45 minutes. The patient is also taught the correct method of brushing and hygiene education. Intervention group: 18 patients should use 0.2% chlorhexidine mouthwash twice a day for 2 weeks, each time at 5 cc for 30 seconds, and avoid eating and drinking for 30 to 45 minutes. The patient is also taught the correct method of brushing and hygiene education. Gingival Index (Sillness & loe). Timepoint: At the beginning of study, seventh day and fourteenth day. Method of measurement: Using a periodontal probe. Plaque Index (Loe & Sillness). Timepoint: At the beginning of study, seventh day and fourteenth day. Method of measurement: Using a periodontal probe. Total colony count. Timepoint: At the beginning of study, seventh day and fourteenth day. Method of measurement: Counting and recording. Ahvaz University of Medical Sciences Approved 2023-02-06 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Jundishapur University, Golestan, Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)