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Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics

This study has been completed.
Information provided by (Responsible Party):
Amir Moeintaghavi, Mashhad University of Medical Sciences Identifier:
First received: December 1, 2010
Last updated: April 7, 2015
Last verified: April 2015
The purpose of this study is to determine whether nonsurgical periodontal therapy is effective in the metabolic control of patients with type II Diabetes mellitus.

Condition Intervention Phase
Metabolic Control Procedure: Scaling and Rootplaning Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Effect of Nonsurgical Periodontal Therapy on Metabolic Control in Patients With Type II Diabetes

Further study details as provided by Amir Moeintaghavi, Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • Metabolic control [ Time Frame: 3 months after treatment ]
    fasting plasma glucose (FPG), HbA1c, TG, TC, high density lipoprotein cholesterol (HDL), and LDL are measured at baseline and 3 months after treatment.

Secondary Outcome Measures:
  • periodontal improvement after scaling and rootplaning [ Time Frame: 3 months after treatment ]
    Periodontal parameters (Plaque index, Gingival index, Clinical Attachment level and Probing depth)are Measured at baseline and 3 months after treatment

Enrollment: 40
Study Start Date: June 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Scalig and Rootplaning
patients will receive scaling and root planing therapy
Procedure: Scaling and Rootplaning
All patients in the test group receive scaling and rootplaning under local anesthesia
Other Names:
  • test group
  • control group
No Intervention: control
patients in control group will not receive periodontal treatment in the time period of the study

Detailed Description:
Type 2 diabetes mellitus (DM2), the most common type of diabetes, is characterized by hyperglycemia, hyperlipidemia, and associated complications. The classic major complications of diabetes are microangiopathy, nephropathy, neuropathy, macrovascular disease, delayed wound healing, and periodontitis. There is an interacting, complex relationship between diabetes and periodontitis.Many studies have shown a greater incidence and a greater severity of periodontitis in diabetic patients.Meanwhile, a number of studies have suggested that periodontitis may actually be a risk factor for diabetic complications as well. This study is performed to investigate the effects of non-surgical periodontal therapy on metabolic control in DM2 patients.

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

(1) mild to moderate periodontitis according to the criteria of the American Academy of Periodontology (32); (2) diagnosis of DM2 with glycated hemoglobin (HbA1c) values over 7%; (3) no major diabetic complications; (4) blood sugar controlled with glybenclamide and metformin, without insulin administration; and (5) no systemic antibiotic administration or periodontal treatment within the last 6 months.

Exclusion Criteria:

(1) presence of systemic diseases other than DM2 that may influence the course of periodontal disease; (2) intake of immunosuppressive drugs, steroids, hydantoin, or non-steroidal anti-inflammatory drugs; (3) tobacco use; (4) pregnancy or intention to become pregnant during the study period; (5) fixed orthodontic appliances; and (5) refusal or inability to give informed consent

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Please refer to this study by its identifier: NCT01252082

Iran, Islamic Republic of
Mashhad Dental School, Mashhad University of Medical Sciences
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735-984
Sponsors and Collaborators
Mashhad University of Medical Sciences
Study Chair: Amir Moeintaghavi, DDS.,Ms. Associate professor,Mashhad Dental School, Mashhad University of Medical Sciences
  More Information

Responsible Party: Amir Moeintaghavi, associate professor of periodontics, Mashhad University of Medical Sciences Identifier: NCT01252082     History of Changes
Other Study ID Numbers: 86067
Study First Received: December 1, 2010
Last Updated: April 7, 2015

Keywords provided by Amir Moeintaghavi, Mashhad University of Medical Sciences:
metabolic control
fasting plasma glucose
glycated hemoglobin processed this record on August 18, 2017