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IRCT20221212056786N2 IRCT 2023-10-03 Yazd University of Medical Sciences Comparison of effectiveness of nigella sativa mouthwash with chlorhexidine mouthwash on improvement of gingivitis Comparison of effectiveness of nigella sativa mouthwash with chlorhexidine mouthwash on improvement of gingivitis 2023-04-04 anticipated 36 Complete https://irct.ir/trial/68513 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to randomly assign qualified people to two groups, the Random allocation software version 2 will be used, and the random allocation method will be also a simple random method. First, the first eligible person will get number 1, and then the eligible people will get number 36, and based on the random allocation done by the software, each person will receive medicine A or B. In order to blind the random allocation, the list of random allocation will be provided to another person who is not in the study and before the patient's visit based on the number, the individual's treatment group will be asked by the third person by phone or SMS, Blinding description: Both mouthwashes will be put in similar bottles, the contents of which are not known. In order to blind the researcher, the researcher herself, who examines and performs the measurements, will have no knowledge of the type of substance inside the bottles. N/A Gingivitis. Intervention 1: Intervention group: This group is given Nigella sativa mouthwash. Patients are told to use 10 milliliters of mouthwash twice a day for 30 seconds for two weeks. The extract is obtained from a grocery in Yazd and used to produce mouthwash. Mouthwash is prepared with a concentration of 20%. Intervention 2: Control group: This group is given chlorhexidine mouthwash. 0.2% chlorhexidine solution (Shahr Daru, Iran) is used twice a day, 10 ml each time, for 30 seconds for two weeks. Yes - There is a plan to make this available What will be shared: All data can be shared When: From February 2023 to 1 year after the publication of the article To whom: For all people, including those working in academic and scientific institutions and industry Conditions: email and call Where to obtain: mohammad arab farashahi, 09133735190, sma.farashahi_69@yahoo.com How to obtain: After sending the email, the data is transferred Comments:
public seyed mohammad arab farashahi
Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd
yazd Iran (Islamic Republic of) 8914881167 +98 35 3625 5881 sma.farashahi_69@yahoo.com Tabriz University of Medical Sciences scientific seyed mohammad arab farashahi
Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd
yazd Iran (Islamic Republic of) 8914881167 +98 35 3625 5881 sma.farashahi_69@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) No attachment loss Probing depth lower than 3 milimeters Under no orthodontics or prosthetic treatments Plaque index 1 or more in 60% areas At least 20 teeth Bleeding on probing in at least 30% of areas 20 years 40 years Both Having a systemic disease Using antibiotics in the last 3 months Allergic to nigella sativa Using drugs affecting periodontium Lack of co-operation in the study Not using the mouthwash for 2 times K05 Gingivitis and periodontal diseases Prevention Prevention Intervention group: This group is given Nigella sativa mouthwash. Patients are told to use 10 milliliters of mouthwash twice a day for 30 seconds for two weeks. The extract is obtained from a grocery in Yazd and used to produce mouthwash. Mouthwash is prepared with a concentration of 20%. Control group: This group is given chlorhexidine mouthwash. 0.2% chlorhexidine solution (Shahr Daru, Iran) is used twice a day, 10 ml each time, for 30 seconds for two weeks. Investigating gingivitis and tooth discoloration after using mouthwash. Timepoint: Examining gingivitis and tooth discoloration at the beginning of the study and after two weeks. Method of measurement: Examining the plaque index using the O'Leary index plaque criterion and bleeding index using the bleeding index criterion and tooth discoloration using the stain index criterion. Educational and research assistant of Shahid Sadoughi University of Medical Sciences, Yazd Approved 2023-01-23 Ethics Committee of Yazd University of Medical Sciences Faculty of Dentistry, Imam Reza Blvd., Kharat Blvd., Daheh Fajr Blvd., Yazd yazd Yazd Iran (Islamic Republic of)