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IRCT20171015036782N9 IRCT 2023-02-14 Yazd University of Medical Sciences the effect of resveratrol on the gingival health of diabetic patients The effect of resveratrol supplementation on clinical parameters and inflammatory markers in diabetic patients with chronic periodontitis 2023-02-20 anticipated 52 Complete https://irct.ir/trial/68509 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The selection of patients and study samples in diabetic and non-diabetic groups is done using the purposive sampling method. The random allocation of the samples to the treatment and control groups will be randomly stratified and based on age and gender (stratified randomization), which means that there will be no significant difference in the average age and gender frequency in the drug and placebo groups, Blinding description: After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups. Dentists are given a table of coded numbers in advance and patients are entered into the study in the order of the numbers in the table. Therefore, the present study is double-blind. Resveratrol and placebo tablets are the same in terms of shape, color and size and are delivered to the patient in the package. 3 Condition 1: Chronic periodontitis. Condition 2: diabetes. Intervention 1: Intervention group: 26 diabetics with moderate to severe chronic periodontitis will be selected after examination and diagnosis of periodontal symptoms and according to the entry and exit criteria and after giving the required information and obtaining written consent. After evaluating the primary and secondary outcomes, non-surgical periodontal treatment will be performed for all patients, and for patients in the 4-week case group, one 600 mg capsule (from Canada's plantvital company) will be prescribed every day during the study period with all patients 3 times in They will be contacted during the week to make sure they have taken their capsules. During the study, all patients will undergo periodontal examinations and treatments, including scaling and leveling of the root surface if needed, and the necessary training for oral and dental hygiene, including the correct way of brushing and flossing, will be given to them, and at the end of the course Patients will be re-examined after 1 month and 3 months. Intervention 2: Control group: 26 diabetics with moderate to severe chronic periodontitis will be selected after examination and diagnosis of periodontal symptoms and according to the entry and exit criteria and after giving the required information and obtaining written consent. After evaluating the primary and secondary outcomes, non-surgical periodontal treatment will be performed for all patients, and patients in the control group will receive 600 mg placebo tablets containing starch every day. Patients will be asked to take these capsules in the morning after eating breakfast. During the study period, all patients will be contacted 3 times a week to ensure that they take their capsules. During the study, all patients will undergo periodontal examinations and treatments, including scaling and leveling of the root surface if needed, and the necessary training for oral and dental hygiene, including the correct way of brushing and flossing, will be given to them, and at the end of the course Patients will be re-examined after 1 month and 3 months. Yes - There is a plan to make this available What will be shared: Only a part of the data, such as the information related to the main result or the like, can be shared. When: The access period starts 6 months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions Conditions: If periodontal and resveratrol treatments affect the severity of diabetes because by providing effective solutions to improve oral and dental health and emphasizing more on hygiene, it is possible to reduce the severity of diabetes and impose heavier costs of this disease in material terms. and spiritually prevented Where to obtain: Conductors of the research project How to obtain: The request for data requires written consent from all the implementers of the research project. Comments:
public Nazanin Roqani Dehkordi
Dahe Fajr Street
yazd Iran (Islamic Republic of) 8914881167 +98 35 2417 3393 nazanin.roghani91@gmail.com Yazd University of Medical Sciences scientific Nazanin Roqani Dehkordi
Dahe Fajr Street
Yazd Iran (Islamic Republic of) 8914881167 +98 35 2417 3393 nazanin.roghani91@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Age between 30-60 years Body mass index (BMI) 18.5 to 30 kg/m2 Patients with confirmed and controlled diabetes mellitus (minimum one year and maximum 5 years since diagnosis) 9>HBA1C Moderate to severe periodontal disease 30 years 60 years Both Patient non-cooperation Diabetes complications such as kidney failure No systemic disease taking medication Pregnancy and breastfeeding smoking Allergy to black grapes or blueberries K05.3 E14 Chronic periodontitis Unspecified diabetes mellitus Treatment - Drugs Placebo Intervention group: 26 diabetics with moderate to severe chronic periodontitis will be selected after examination and diagnosis of periodontal symptoms and according to the entry and exit criteria and after giving the required information and obtaining written consent. After evaluating the primary and secondary outcomes, non-surgical periodontal treatment will be performed for all patients, and for patients in the 4-week case group, one 600 mg capsule (from Canada's plantvital company) will be prescribed every day during the study period with all patients 3 times in They will be contacted during the week to make sure they have taken their capsules. During the study, all patients will undergo periodontal examinations and treatments, including scaling and leveling of the root surface if needed, and the necessary training for oral and dental hygiene, including the correct way of brushing and flossing, will be given to them, and at the end of the course Patients will be re-examined after 1 month and 3 months. Control group: 26 diabetics with moderate to severe chronic periodontitis will be selected after examination and diagnosis of periodontal symptoms and according to the entry and exit criteria and after giving the required information and obtaining written consent. After evaluating the primary and secondary outcomes, non-surgical periodontal treatment will be performed for all patients, and patients in the control group will receive 600 mg placebo tablets containing starch every day. Patients will be asked to take these capsules in the morning after eating breakfast. During the study period, all patients will be contacted 3 times a week to ensure that they take their capsules. During the study, all patients will undergo periodontal examinations and treatments, including scaling and leveling of the root surface if needed, and the necessary training for oral and dental hygiene, including the correct way of brushing and flossing, will be given to them, and at the end of the course Patients will be re-examined after 1 month and 3 months. Probing depth. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 3 months after the start of the study. Method of measurement: With Probe Williams. Clinical Attachment Level. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 3 months after the start of the study. Method of measurement: With Probe Williams. Plaque index. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 3 months after the start of the study. Method of measurement: The percentage of plaque accumulation around the surfaces of the teeth after evaluation with a revealing substance. Bleeding index. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 3 months after the start of the study. Method of measurement: Percentage of bleeding around all teeth after 30 seconds following probing. IL-1β. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 3 months after the start of the study. Method of measurement: The amount of interleukin IL-1β per unit volume of saliva. IL-8. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 3 months after the start of the study. Method of measurement: The amount of interleukin IL-8 per unit volume of saliva. HBA1C. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 3 months after the start of the study. Method of measurement: blood test. FBS. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 3 months after the start of the study. Method of measurement: From the kit by the enzymatic method. Body mass index. Timepoint: At the beginning of the study (before the start of the intervention) and 1 month and 3 months after the start of the study. Method of measurement: BMI is calculated using height and weight. BMI = weight (kilograms) / (height) 2 (square meters). Yazd University of Medical Sciences Approved 2022-07-11 Ethics committee of Yazd University of Medical Sciences Shahid Bahonar square Yazd Yazd Iran (Islamic Republic of)