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IRCT20210404050830N1 IRCT 2021-11-12 Karaj University of Medical Sciences effect of maouthwash contains punica granatum extract on periodontitis Evaluation the effect of mouth wash contains punica granatum extract in comparison with chlorhexidine mouth wash on improvement of periodontal index in chronic mild to moderate periodontitis 2021-04-09 anticipated 30 Complete https://irct.ir/trial/55324 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the block randomization method. This method is usually used to balance the number of samples assigned to each of the study groups. The size of all blocks is equal and in this two-group experiment, we will have 4 blocks of 8 (including 4 people participating in the intervention group and 4 people participating in the control group), Due to the possibility of people not attending the follow-up sessions, 2 people are considered more than the sample size. The site https://www.sealedenvelope.com/simple has been used for random assignment of individuals to groups. In this method we use sealed envelopes with a random sequence. Each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes open in order and the assigned group of the participant is revealed, Blinding description: The codes for each group will be kept in a closed envelope. After the person is eligible to enter the study, based on the obtained sequence, one of the two interventions will be performed for him. The solutions are in the same jars and are similar in color and size, and no one untill the end of the study, when the research report is being prepared, neither the researcher, nor the assistant, nor the participant has any knowledge that labels A or B belong to the intervention or control group. 3 Chronic mild to moderate periodontitis.. Intervention 1: Intervention group 1: Before any intervention,The patient will be taught how to brush and floss properly and how to use mouthwash properly for 15 minutes.Then all the variables, including the depth of the periodontal pocket and gingival index and clinical attachment loss and bleeding during probing(by WHO periodontal probe) and bacterial culture are recorded in the patient's file at the first meeting before any intervention. Then scaling is done by ultrasonic scaler for the patient. up to two weeks after scaling the patient uses mouthwash containing 2 percent punica granatum extract that produced by Pharmacy Faculty of Alborz University of Medical Sciencestwice a day. 1 month later and 3 months after scaling, the patient is called to re-examine the gingival markers. Then the results are compared with the results of control group. Intervention 2: control group: Before any intervention,The patient will be taught how to brush and floss properly and how to use mouthwash properly for 15 minutes.Then all the variables, including the depth of the periodontal pocket and gingival index and the amount ofclinical attachment loss and bleeding during probing(by WHO periodontal probe) and bacterial culture are recorded in the patient's file at the first meeting before any intervention. Then scaling is done by ultrasonic scaler for the patient. up to two weeks after scaling the patient uses mouthwash containing 0.2 percent chlorhexidine(NAJO) twice a day. 1 month later and 3 months after scaling, the patient is called to re-examine the gingival markers. 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 right now I didnt make decision to publish or not.
public Ali Bayat
Number20, West 5th, Tohid ave,Tehranpars, Tehran
Tehran Iran (Islamic Republic of) 1653636411 +98 21 4465 4507 alibt77@gmail.com Karaj University of Medical Sciences scientific Ali Bayat
Number 20, west 5th, street Tohid ave., Tehranpars, Tehran
Tehran Iran (Islamic Republic of) 1653636411 +98 21 4465 4507 alibt77@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) not alcohol consumer non smoker not pregnant no antibiotic usage no allergic reaction not breastfeeding no systematic disease mild to moderate chronic periodontitis 18 years no limit Both K05.3 Chronic periodontitis Treatment - Other Treatment - Other Intervention group 1: Before any intervention,The patient will be taught how to brush and floss properly and how to use mouthwash properly for 15 minutes.Then all the variables, including the depth of the periodontal pocket and gingival index and clinical attachment loss and bleeding during probing(by WHO periodontal probe) and bacterial culture are recorded in the patient's file at the first meeting before any intervention. Then scaling is done by ultrasonic scaler for the patient. up to two weeks after scaling the patient uses mouthwash containing 2 percent punica granatum extract that produced by Pharmacy Faculty of Alborz University of Medical Sciencestwice a day. 1 month later and 3 months after scaling, the patient is called to re-examine the gingival markers. Then the results are compared with the results of control group. control group: Before any intervention,The patient will be taught how to brush and floss properly and how to use mouthwash properly for 15 minutes.Then all the variables, including the depth of the periodontal pocket and gingival index and the amount ofclinical attachment loss and bleeding during probing(by WHO periodontal probe) and bacterial culture are recorded in the patient's file at the first meeting before any intervention. Then scaling is done by ultrasonic scaler for the patient. up to two weeks after scaling the patient uses mouthwash containing 0.2 percent chlorhexidine(NAJO) twice a day. 1 month later and 3 months after scaling, the patient is called to re-examine the gingival markers. Periodontal pocket depth. Timepoint: before intervention, after 1 month, after 3 month. Method of measurement: with WHO periodontal probe. Clinical attachement loss. Timepoint: before intervention, after 1 month, after 3 month. Method of measurement: with WHO periodontal probe. Gingival index. Timepoint: before intervention, after 1 month, after 3 month. Method of measurement: with WHO periodontal probe. Bleeding on probing. Timepoint: before intervention, after 1 month, after 3 month. Method of measurement: with WHO periodontal probe. Bacterial culture. Timepoint: before intervention, after 1 month, after 3 month. Method of measurement: pharmacoupe culture. Karaj University of Medical Sciences Approved 2021-01-19 Ethics committee of Alborz University of Medical Sciences Katooei st, Golshahr, Karaj Karaj Alborz Iran (Islamic Republic of)