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

Comparing the effectiveness of mouthwash containing green tea extract and pomegranate peel, with and without zinc, compared to 0.12% chlorhexidine mouthwash on gingivitis.

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 105 patients. For random allocation, it is based on 6 random blocks, the sequence list of which will be determined through Random Allocation Software and will be placed in three groups.

The patients referred to the periodontology department of Gilan Faculty of Dentistry were asked to rinse twice a day (after brushing their teeth) for two weeks at the rate of 10 ml each time. After two weeks, the PBI (Papillary Bleeding Index), MGI (Modified Gingival Index), PI (Plaque Index) will be measured in patients. In this double-blind study, the researcher and researcher will be blinded. In this way, the mouthwashes were packed in the same size opaque white bottles so that the bottles are not distinguished from each other in terms of appearance. Data related to the type of mouthwash used by each group will not be provided to the statistician.

Entry criteria: 18 to 65 years old, having at least 20 natural teeth Exclusion criteria: patients with systemic diseases such as diabetes mellitus, pregnant and lactating women, smokers or tobacco users

Group A and B will be the intervention, and the people of these groups will be given pomegranate peel extract-green tea-zinc mouthwash and pomegranate peel extract-green tea mouthwash respectively, and group C, which is the control group, will be given 0.12% chlorhexidine. All patients are asked to rinse their mouth twice a day (after brushing) in the amount of 10 ml each time for two weeks.

PBI(papillary Bleeding Index) ،MGI(Modified Gingival Index) ،PI(Plaque Index)

Random allocation was based on 6 random blocks, whose sequence list was determined by Random Allocation Software and placed in three groups.

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.