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IRCT20150210021029N2 IRCT 2020-05-17 Esfahan University of Medical Sciences Effect of Propolis Gel under Dressing of periodontal flap surgery Evaluation of Propolis Gel Under the Periodontal Dressing (Coe-Pack® GC America INC) on Gingival Healing Index After Periodontal Flap Surgery 2020-05-26 anticipated 20 Complete https://irct.ir/trial/47956 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: Participants in the study were selected by Simple Randomization method, individually and with Random number table tools. The intervention was performed as Split-Mouth, and the choice of Quadrant for Intervention or Control was randomly performed with Coin instruments, Blinding description: Participant: In this study, due to the presence of surgical Drapes, it is not possible to detect the direction in which the Propolis and Placebo are located Data Analyzer: Data is evaluated as a number without specifying the position of the Propolis and the Placebo Researcher and evaluator: The first side of each person is selected by the flip coin method and put in group A, which is aware of the clinical caregiver, and the other side is in group B. gel and placebo have A and B labels. 3 Periodontal flap surgery. Intervention 1: Intervention group: After the surgery, we use the 20% Propolis gel, which is made by the Company that produces the Propolis (Green Plants of Life Company) under the Coe Pack( GC America inc), and then we mix the Coe Pack completely and place it on the surgical site. Intervention 2: Control group: After the periodontal flap surgery, we put the Placebo gel and then put the Coe Pack( GC America inc) dressing on the desired place. Yes - There is a plan to make this available What will be shared: Document Title: Data related to Personal information and Indicators examined in the study. All Data can be shared after People have not been identified When: Up to One year after publication of the Article To whom: Researchers working in Academic and Scientific Institutions Conditions: In addition to mentioning the Name and Academic affiliation, the Applicant must have signed a letter stating that He or She does not intend to publish or use any of our study Data in Person Where to obtain: Applicants can contact this E-mail: skiani.dnt@gmail.com How to obtain: The Project Manager will provide the requested Documents via E-mail no later than One week after receiving the E-mail from the Applicant Comments:
public Sima Kiani
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave, Isfahan
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 5542 skiani.dnt@gmail.com Esfahan University of Medical Sciences scientific Sima Kiani
Faculty of Dentistry, Isfahan University of Medical Sciences, Hezarjerib Ave, Isfahan
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 5542 skiani.dnt@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with moderate to severe chronic Periodontitis require two side or whole mouth periodontal flap surgery that is systemically healthy The same type of flap on both sides in each person Age over 18 years Pelaque index ≤ 1 after health education No contraindications for surgery No need to cut more than 2 mm of bone No need for prophylactic Antibiotics Do not take Corticosteroids or Hormones for the past two months Having acceptable cooperation 18 years no limit Both Smoking Pregnancy Taking anti-inflammatory drugs or Antibiotics Existence of systemic disease Pelaque index 2 or 3 after health education Need to cut more than 2 mm of bone Lack of cooperation and patient satisfaction K05.6 Periodontal disease, unspecified Treatment - Drugs Placebo Intervention group: After the surgery, we use the 20% Propolis gel, which is made by the Company that produces the Propolis (Green Plants of Life Company) under the Coe Pack( GC America inc), and then we mix the Coe Pack completely and place it on the surgical site. Control group: After the periodontal flap surgery, we put the Placebo gel and then put the Coe Pack( GC America inc) dressing on the desired place Gingival healing index. Timepoint: One week after surgery, Two weeks after surgery, One month after surgery. Method of measurement: The healing rate is assessed based on tissue color, probe bleeding, granular tissue, cut margin, and discharge with five excellent, very good, good, weak, and very weak words. Pelaque index. Timepoint: Before surgery, One week after surgery, Two weeks after surgery and One month after surgery. Method of measurement: Based on the Silness and Loe method, it is evaluated in which the absence of Plaque(grade 0) to very large Plaque(grade 3) is ranked. Papillary bleeding index. Timepoint: Before surgery, One week after surgery, Two weeks after surgery and One month after surgery. Method of measurement: It shows the rate of papillary bleeding by probe in 4 ranks, from non-bleeding (grade 0) to spontaneous bleeding (grade 3). Pain index. Timepoint: Before surgery, One week after surgery, Two weeks after surgery and One month after surgery. Method of measurement: By the Visual Analog Scale form. Esfahan University of Medical Sciences Approved 2020-02-25 Ethics Committee of Isfahan University of Medical Sciences Isfahan university of medical sciences, Hezarjerib Ave, Isfahan Isfahan Isfehan Iran (Islamic Republic of)