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IRCT20231123060153N3 IRCT 2025-05-20 Gorgan University of Medical Sciences Evaluation of the effect of non-surgical periodontal treatment on biochemical indicators of metabolic syndrome Evaluation of the effect of non-surgical periodontal treatment on biochemical indicators of metabolic syndrome: A Controlled Randomized Clinical Trial 2025-04-29 anticipated 54 Complete https://irct.ir/trial/83120 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients would be randomized into two groups by Randomized block method with blocks of size 4. The website sealed envelope with https://sealedenvelope.com address will be used to prepare a random list of patients and this work is prepared by a project associate who has no role in treating patients. To keep the random list hidden until the beginning of patients treatment, opaque and identical envelopes will be used. Each envelope will have the patient number written on it and the treatment the patient should receive. Given that in this study, the intervention will include scaling of the patients' teeth, there is no possibility of blinding the patient and the treating physician to the treatment the patient will receive, and the patient and the treating dentist are aware of the type of treatment the patients will receive. N/A Condition 1: Metabolic syndrome. Condition 2: Non-surgical periodontal treatment. Condition 3: Chronic periodontitis. Intervention 1: Intervention group:The intervention group treatment is built on oral health education and non-surgical periodontal therapy.The oral health educations content consists brushing techniques and frequency and flossing, which will be demonstrated to all patients in a one on one oral health instruction (OHI) session in dental school by a certified instructor which is the dentistry student who is in charge of the research. In the second step, treatment which is non-surgical periodontal therapy with a Woodpecker model:UDSL piezoelectric device will be delivered to the intervention group in a single session with no time limit.The treatment will contain plaque removal as a result of supra- and sub-gingival scaling,using the device mentioned prior in the text, Plaque control, root planing using a periodontal curette, and chemical agents such as Chlorhexidine mouthwash with 0.2% concentration as an adjunct. after that ,a monthly plaque control program will be executed by the operator on phone calls. patients will be clinically examined in 3 and 6 months afterwards and clinical periodontal parameters, fasting blood sugar, blood lipids, abdominal obesity and blood pressure will be assessed and compared to pre-treatment parameters. Intervention 2: Control group: In the control group, only oral health education will be used. The content of health education, including: the correct number and method of brushing and flossing, will be presented orally and individually to all patients in the control group at the beginning of the study in the dental school by the dental student implementing the project.Then, both the measurement of factors related to periodontal conditions and the measurement of metabolic syndrome factors will be performed by the dental student when the patient visits the dental school. After that, the monthly plaque control program is also followed up by the operator over the phone. Control group will be examined 3 months and 6 months later, and their clinical periodontal parameters, fasting blood sugar, blood lipids, abdominal obesity, and blood pressure will be examined and compared with before treatment. 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 There is no further information
public Amir reza Ahmadinia
Faculty of dentistry, Golestan University of Medical Sciences, 5th Shahriar, Shahriar town
Gorgan Iran (Islamic Republic of) 4916648679 +98 17 3253 6270 ar.ahmadinia@gmail.com Gorgan University of Medical Sciences scientific Amir reza Ahmadinia
Faculty of dentistry, Golestan University of Medical Sciences, 5th Shahriar, Shahriar town
Gorgan Iran (Islamic Republic of) 4916648679 +98 17 3253 6270 ar.ahmadinia@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Patients with 1st or 2nd Stage of periodontitis Ages between 35 to 60 Definitive metabolic syndrome diagnosis in both groups Having at least 20 teeth Consent for participation 35 years 60 years Both Having any kind of disease that could effect periodontal tissue other than matabolic syndrome like: Papillon-lefevre، Treacher Collins، Aggressive periodontitis، AIDS and End Stage Renal Disease Taking any medication that could effect periodontal tissue such as: Nifedipine and Phenytoin Using orthodontic treatments or fixed long span prostheses or removable prostheses Taking Anti-biotics، Immunosuppressive drugs or Non-steroidal anti-inflammatory drugs for one week in last six month Using periodontal treatment in last six month E88.81 K05.3 Metabolic syndrome Chronic periodontitis Treatment - Other Treatment - Other Intervention group:The intervention group treatment is built on oral health education and non-surgical periodontal therapy.The oral health educations content consists brushing techniques and frequency and flossing, which will be demonstrated to all patients in a one on one oral health instruction (OHI) session in dental school by a certified instructor which is the dentistry student who is in charge of the research. In the second step, treatment which is non-surgical periodontal therapy with a Woodpecker model:UDSL piezoelectric device will be delivered to the intervention group in a single session with no time limit.The treatment will contain plaque removal as a result of supra- and sub-gingival scaling,using the device mentioned prior in the text, Plaque control, root planing using a periodontal curette, and chemical agents such as Chlorhexidine mouthwash with 0.2% concentration as an adjunct. after that ,a monthly plaque control program will be executed by the operator on phone calls. patients will be clinically examined in 3 and 6 months afterwards and clinical periodontal parameters, fasting blood sugar, blood lipids, abdominal obesity and blood pressure will be assessed and compared to pre-treatment parameters. Control group: In the control group, only oral health education will be used. The content of health education, including: the correct number and method of brushing and flossing, will be presented orally and individually to all patients in the control group at the beginning of the study in the dental school by the dental student implementing the project.Then, both the measurement of factors related to periodontal conditions and the measurement of metabolic syndrome factors will be performed by the dental student when the patient visits the dental school. After that, the monthly plaque control program is also followed up by the operator over the phone. Control group will be examined 3 months and 6 months later, and their clinical periodontal parameters, fasting blood sugar, blood lipids, abdominal obesity, and blood pressure will be examined and compared with before treatment. Fasting blood sugar factor value in blood test. Timepoint: Measuring the level of fasting blood sugar before the intervention and 3 and 6 months after the end of intervention. Method of measurement: Glucometer. Triglycerides factor value in blood test. Timepoint: Measuring the level of triglyceride before the intervention and 3 and 6 months after the end of intervention. Method of measurement: Triglyceride Oxidase method. Cholesterol factor value in blood test. Timepoint: Measuring the level of cholesterol before the intervention and 3 and 6 months after the end of intervention. Method of measurement: Cholesterol Oxidase method. HDL factor value in blood test. Timepoint: Measuring the level of HDL before the intervention and 3 and 6 months after the end of intervention. Method of measurement: Enzymatic method. Abdominal obesity in centimeters. Timepoint: Measuring the level of abdominal obesity before the intervention and 3 and 6 months after the end of intervention. Method of measurement: Tape measure. Blood pressure. Timepoint: Measuring Blood pressure before the intervention and 3 and 6 months after the end of intervention. Method of measurement: Mercury sphygmomanometer. Gingival recession. Timepoint: Measuring the amount of gingival recession before the intervention and 3 and 6 months after the end of the intervention. Method of measurement: Williams periodontal probe. Clinical Attachment Loss. Timepoint: Measurement of clinical attachment loss before intervention and 3 and 6 months after the end of intervention. Method of measurement: Williams periodontal probe. Pocket probing depth. Timepoint: Measurement of pocket probe depth before intervention and 3 and 6 months after the end of intervention. Method of measurement: Williams periodontal probe. Plaque index. Timepoint: Measurement of plaque index before intervention and 3 and 6 months after the end of intervention. Method of measurement: Silness & Loe index. Bleeding on probing. Timepoint: Measurement of bleeding on probing before the intervention and 3 and 6 months after the end of the intervention. Method of measurement: Williams periodontal probe. Gorgan University of Medical Sciences Approved 2025-04-20 Ethics Committee of Golestan University of Medical Sciences Falsafi Higher Education Complex, The beginning of Shasat Kola Road, Gorgan Gorgan Golestan Iran (Islamic Republic of)