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IRCT20190721044287N1 IRCT 2019-12-21 Rasht University of Medical Sciences Effect of non surgical periodontal therapy in treatment of diabetes Evaluation of effect of nonsurgical periodontal therapy on hemoglobin A1c and c1 reactive protein value in type 2 diabetes mellitus pateints. 2019-10-23 anticipated 42 Complete https://irct.ir/trial/41597 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The research units were divided into two groups of intervention and control, using six-dimensional permutation blocks. First, possible blocks are listed (AAABBB, ABABAB, BABABA, BBABAA and ….) and each block is assigned a number. Then, using a random number table, a number is chosen. The subjects are assigned to the intervention and control groups based on the block corresponding to the chosen number. This will continue until the sample size is complete. N/A Condition 1: moderate chronic periodontitis. Condition 2: Type 2 diabetes mellitus. Intervention 1: In intervention group scaling and root planning are performed for patients by an ultrasonic device with slim head in a one hour session . supra gingival and sub gingival calculus is removed. presence of calculus is checked by an explorer. If needed, hand instrument is used for sites which are out of access. Patients are prescribed tooth brushing with modified bass technique (twice daily), using dental floss (once a day) and chlorhexidine 0.12% twice a day. Intervention 2: In control group scaling and root planing are not performed. Patients are prescribed tooth brushing with modified bass technique (twice daily), using dental floss (once a day) and chlorhexidine 0.12% twice a day. after the study ends, Scaling and root planing will be performed for control group. Yes - There is a plan to make this available What will be shared: All data relative to measured index are shared after unidentifying patients. When: 6 months or 1 year after the publication of final results To whom: Anyone can access the data Conditions: In order to design and perform similar research or as a base for more development studys Where to obtain: Rashed Ghorbandoust: rashed.ghd@gmail.com Dr Mohammad Moshtaghi moghadam: Dr.moshtaghi@gums.ac.ir How to obtain: After sending an email and explaining about the study, they will receive the data in a month. Comments:
public Rashed Ghorbandoust
Dentistry Faculty, GUMS Complex, Fuman_saravan Ring Road
Rasht Iran (Islamic Republic of) 4194173774 +98 13 3324 2361 rashed.ghd@gmail.com Rasht University of Medical Sciences scientific Mohammad Moshtaghi Moghadam
Dentistry Faculty, GUMS Complex, Fuman-saravan Ring Road
Rasht Iran (Islamic Republic of) 4194173744 +98 13 3348 6406 Dr.moshtaghi@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with chronic periodontitis who have not received any periodontal treatment in the past 6 months Periodontal patients who have not received any antimicrobial treatment in the past 3 months Patients with at least 14 teeth in mouth and pocket depth ≥ 5 mm in at least 4 areas and clinical attachment loss ≥3 mm in at least 4 areas Diabetes diagnosed by a physician for about 6 months Patients unchanged in their diabetic drug regimen for the past 3 months no limit no limit Both Patients with advanced diabetic problems (macrovascular and microvascular) Chronic pulmonary disease Kidney and liver disease Malignancies Heart disease (coronary artery disease) Transplanted patients History of infection and trauma Alcoholic and Smoker Patients Pregnant people Patients with severe periodontitis K05.3 E11 Chronic periodontitis Type 2 diabetes mellitus Treatment - Devices Treatment - Devices In intervention group scaling and root planning are performed for patients by an ultrasonic device with slim head in a one hour session . supra gingival and sub gingival calculus is removed. presence of calculus is checked by an explorer. If needed, hand instrument is used for sites which are out of access. Patients are prescribed tooth brushing with modified bass technique (twice daily), using dental floss (once a day) and chlorhexidine 0.12% twice a day. In control group scaling and root planing are not performed. Patients are prescribed tooth brushing with modified bass technique (twice daily), using dental floss (once a day) and chlorhexidine 0.12% twice a day. after the study ends, Scaling and root planing will be performed for control group. Hb A1c. Timepoint: At baseline and 3 months later. Method of measurement: Sebia apparatus for measuring Hba1c using electrophoresis capillary kit. C1 Reactive Protein. Timepoint: At baseline and 3 month later. Method of measurement: Hitachi912 apparatus for measuring c1 reactive protein using bionik kit. Clinical attachment loss index. Timepoint: At baseline and 3 months later. Method of measurement: Using William's periodontal probe. Gingival index. Timepoint: At baseline and 3 month later. Method of measurement: Using Leo & Sillness gingival inflammation index. Pocket depth index. Timepoint: At baseline and 3 month later. Method of measurement: Using William's periodontal probe. Gingival bleeding index. Timepoint: At baseline and 3 month later. Method of measurement: Using William's periodontal probe. Plaque index. Timepoint: At baseline and 3 month later. Method of measurement: Using disclosing agent by O'leary Index method. Rasht University of Medical Sciences Approved 2019-09-07 Ethics Committee of Guilan University of Medical Sciences Dental Faculty,GUMS Complex, Fuman_Saravan Ring Road, Rasht Guilan Iran (Islamic Republic of)