Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01252082
Recruitment Status : Completed
First Posted : December 2, 2010
Last Update Posted : April 8, 2015
Information provided by (Responsible Party):
Amir Moeintaghavi, Mashhad University of Medical Sciences

Brief Summary:
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 or disease Intervention/treatment Phase
Metabolic Control Procedure: Scaling and Rootplaning Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : June 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: Amir Moeintaghavi, associate professor of periodontics, Mashhad University of Medical Sciences Identifier: NCT01252082     History of Changes
Other Study ID Numbers: 86067
First Posted: December 2, 2010    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by Amir Moeintaghavi, Mashhad University of Medical Sciences:
metabolic control
fasting plasma glucose
glycated hemoglobin