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IRCT20180130038558N1 IRCT 2021-11-28 Mashhad University of Medical Sciences Effect of propolis on generalized chronic gingivitis Evaluation of the effectiveness of mucoadhesive mouthwash containing propolis extract formulation on prevention and improvement of symptoms in patients with generalized chronic gingivitis 2021-12-01 anticipated 78 Complete https://irct.ir/trial/59613 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by block method, the size of blocks is equal to six with three members A and B and C in a ratio of 1: 1:1. Based on the sample size, 13 blocks are numbered in a different order from 1 to 13 and a random sequence of 13 blocks is determined using the site " http://www.randomization.com", then the sequence of treatment groups A and B and C is determined in envelopes with number 1 Up to 78, with the inclusion of each eligible person, the envelope corresponding to the person's number is opened and the treatment group is determined, Blinding description: Due to the use of a placebo similar to the intervention treatment, the physician associated with the participants and participants will not be informed of the assigned treatment. Also, the analyst will be unaware of the treatment assigned to the three groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B and C. The placebo will be very similar in treatment in terms of shape, consistency, packaging, and smell. 2 Generalized Chronic Gingivitis. Intervention 1: Intervention group: mucoadhesive mouthwash with 5% propolis that every patient should use and rinse mouthwash for 30 seconds twice a day for 14 days and avoid eating and drinking for 30 minutes after use. Intervention 2: Control group: Cholorhexidin mouthwash that every patient should use and rinse mouthwash for 30 seconds twice a day for 14 days and avoid eating and drinking for 30 minutes after use. Intervention 3: Control group: Placebo mouthwash containing the base of propolis mouthwash that is the same as coloring, tasting, smelling and appearance. Every patient should use and rinse mouthwash for 30 seconds twice a day for 14 days and avoid eating and drinking for 30 minutes after use. 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 Dr. Nasser Sargolzaei
At the beginning of Vakilabad Boulevard, in front of Mellat Park - School of Dentistry
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3806 7100 sargolzaen@mums.ac.ir Mashhad University of Medical Sciences scientific Naser Sargolzaei
At the beginning of Vakilabad Boulevard, in front of Mellat Park - School of Dentistry
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3806 7100 sargolzaien@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patient does not have a systemic problem Patient has generalized chronic gingivitis Patient has filled out an informed consent form Patient has no history of smoking 18 years 60 years Both Pregnant patients Patients who are unable to attend in follow up sessions Patients receiving antibiotics systemically or topically Breastfeeding patients Using anti-inflammatory medications during the study Using anti-coagulant medications during the study Using immune-suppressive medications during the study Patients receiving orthodontic therapy K05.1 Chronic gingivitis Treatment - Drugs Treatment - Drugs Placebo Intervention group: mucoadhesive mouthwash with 5% propolis that every patient should use and rinse mouthwash for 30 seconds twice a day for 14 days and avoid eating and drinking for 30 minutes after use. Control group: Cholorhexidin mouthwash that every patient should use and rinse mouthwash for 30 seconds twice a day for 14 days and avoid eating and drinking for 30 minutes after use. Control group: Placebo mouthwash containing the base of propolis mouthwash that is the same as coloring, tasting, smelling and appearance. Every patient should use and rinse mouthwash for 30 seconds twice a day for 14 days and avoid eating and drinking for 30 minutes after use. Examination of plaque indices. Timepoint: At the beginning of the study (before the start of the SRP) and 14 days later. Method of measurement: observation and check list of Turesky modification of the Quigley-Hein Plaque (MQH) Index. Bleeding on probing (BoP). Timepoint: At the beginning of the study (before the start of the SRP) and 14 days later. Method of measurement: observation and check list of Gingival bleeding index (GBI). Examination of gingival index. Timepoint: At the beginning of the study (before the start of the SRP) and 14 days later. Method of measurement: observation and check list of Modified Gingival Index (MGI). Mashhad University of Medical Sciences Approved 2021-10-22 Ethics committee of Mashhad University of Medical Science Vakil Abad Blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)