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IRCT20200919048760N1 IRCT 2020-09-23 Gorgan University of Medical Sciences Assessment of the effect of local application of Aloe Vera gel in treatment of gum inflammation in diabetic patients Assessment of the effect of local application of Aloe Vera gel as a non-surgical adjunctive treatment in type 2 diabetic patients with chronic periodontitis referring to Gorgan dental school 2020-09-26 anticipated 44 Complete https://irct.ir/trial/51149 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method is split mouth so that randomly with a pre-prepared randomization list in a quadrant of each patient's jaw, scaling and root planing with local application of aloe vera gel (test group) and in the opposite quadrant Jaw scaling and root planing will be done alone (control group), Blinding description: After applying the gel, all treated areas will be covered with periodontal dressing (coe pack) for 24 hours. The purpose of placing periodontal dressings in test areas is to prevent the gel from being washed away by saliva and to create a longer effect. The purpose of placing periodontal dressing in control areas is to blind the patient. 3 Condition 1: Type 2 diabetic patients with chronic periodontitis. Condition 2: Type 2 diabetic patients with chronic periodontitis. Intervention group: The procedure will be in the form of a split mouth in such a way that randomly with a pre-prepared randomization list, half of one patient's jaw is treated only with scaling and root planing (control group) and half The other jaw will be treated with scaling and root planing with local application of aloe vera gel (test group). In the control quadrant, scaling areas and planing of roots and gingival pockets are routinely washed with distilled water. The aloe vera gel used in this study contains 98% pure aloe vera gel obtained from the leaves of the aloe vera plant plus 2% emulsifier. To prepare the gel, first wash the leaves of aloe vera with water and then disinfect them. Remove the green leaf part of the leaf and keep the gel released from it in a sterile container. The emulsifier has no therapeutic properties and its purpose is only to stabilize and maintain the gel state. The gel is inserted passively through an insulin syringe from the base of the periodontal pocket to the marginal edge of the patient's gums without applying any force so that some of the gel leaks out of the gingival margin. One week after the first stage of treatment, the patient will be placed the gel again.. Yes - There is a plan to make this available What will be shared: Patients' periodontal charts will be published, which include details of the variables. When: The start of the document access period is a maximum of 1 year after the results are published. To whom: The research documents will be provided to academic researchers. Conditions: The documentation of this study should be used in order to make researchers more familiar with how to record data for further studies. Where to obtain: To receive the documents, send a message to Ida.mirzaee65@gmail.com in the name of Dr. Aida Mirzaei. How to obtain: The study documents will be sent to the applicant researcher after verifying his / her identity. Comments:
public Iman Zarei Sani
Faculty of Dentistry, Gorgan University of Medical Sciences, Shahriar Ave 5, Shahriar town
Gorgan Iran (Islamic Republic of) 4913983635 +98 17 3262 7824 zarei.i@goums.ac.ir Gorgan University of Medical Sciences scientific Aida Mirzaee
Faculty of Dentistry, Gorgan University of Medical Sciences, Shahriar Ave 5, Shahriar town
Gorgan Iran (Islamic Republic of) 4913983635 +98 17 7824 3262 Ida.mirzaee65@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetic patients Being over 18 years old Having at least 20 teeth in the mouth Having at least one area with an pocket depth of 4 mm and more and with a loss of clinical attachment of 3 mm and more in four or more teeth in at least two quadrants The need for availability during the research process Having conscious satisfaction 18 years no limit Both Receive systemic or topical antibiotic therapy in the last 3 months Consumption of antioxidants including vitamin C or E in the last 3 months Receive scaling and root planing treatment in the last 6 months History of any periodontal treatment, both surgical and non-surgical, during the last 6 months Patients undergoing orthodontic treatment Patients with uncontrolled diabetes (HbA1C> 7) Tobacco consumption alcohol consumption Patients with aggressive periodontitis Pregnancy and lactation Treatment - Drugs Intervention group: The procedure will be in the form of a split mouth in such a way that randomly with a pre-prepared randomization list, half of one patient's jaw is treated only with scaling and root planing (control group) and half The other jaw will be treated with scaling and root planing with local application of aloe vera gel (test group). In the control quadrant, scaling areas and planing of roots and gingival pockets are routinely washed with distilled water. The aloe vera gel used in this study contains 98% pure aloe vera gel obtained from the leaves of the aloe vera plant plus 2% emulsifier. To prepare the gel, first wash the leaves of aloe vera with water and then disinfect them. Remove the green leaf part of the leaf and keep the gel released from it in a sterile container. The emulsifier has no therapeutic properties and its purpose is only to stabilize and maintain the gel state. The gel is inserted passively through an insulin syringe from the base of the periodontal pocket to the marginal edge of the patient's gums without applying any force so that some of the gel leaks out of the gingival margin. One week after the first stage of treatment, the patient will be placed the gel again. Probing pocket depth (PPD) in millimeters Clinical attachment level (CAL) in millimeters Gingival index (GI) in terms of graded determination plaque index (PI) in percentage. Timepoint: The time of measurement of variables is at the beginning of the study (before the intervention), 1 month and 3 months after treatment. Method of measurement: probing pocket depth (PPD) in millimeters by Williams periodontal probe Clinical attachment level (CAL) in millimeters by Williams periodontal probe. Gingival index (GI) according to the assigned grading: GI0 (normal): Pink gums Normal, non-inflammatory GI1 (mild): Slightly discolored gums, Negative BOP GI2 (moderate): Red, shiny, swollen gums, Positive BOP GI3 (severe): Gums red, swollen, with spontaneous sores and bleeding / Examination with periodontal probe . Plaque index (PI): How to measure PI: (Number of painted surfaces * 100) / (Number of teeth * 4) Percentage: Optimal: 0-30 Medium: 31-50 Unfavorable: 51-100. Gorgan University of Medical Sciences Approved 2020-06-14 Ethics committee of Gorgan University of Medical Sciences Faculty of Dentistry, Gorgan University of Medical Sciences, Shahriar Ave 5, Shahriar town Gorgan Golestan Iran (Islamic Republic of)