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Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amir Moeintaghavi, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01252082
First received: December 1, 2010
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Metabolic control [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 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
 Procedure: Scaling and Rootplaning
All patients in the test group receive scaling and rootplaning under local anesthesia
Other Names:
  • test group
  • control group

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252082

Locations
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
Investigators
Study Chair: Amir Moeintaghavi, DDS.,Ms. Associate professor,Mashhad Dental School, Mashhad University of Medical Sciences
  More Information

Publications:

Responsible Party: Amir Moeintaghavi, associate professor of periodontics, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01252082     History of Changes
Other Study ID Numbers: 86067
Study First Received: December 1, 2010
Last Updated: April 5, 2012
Health Authority: Iran: Ethics Committee

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

ClinicalTrials.gov processed this record on May 21, 2013