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Clinical Trials/NCT01252082
NCT01252082
Completed
Phase 2

Evaluation of Effect of Nonsurgical Periodontal Therapy on Metabolic Control in Patients With Type II Diabetes

Mashhad University of Medical Sciences1 site in 1 country40 target enrollmentJune 2007

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Metabolic Control
Sponsor
Mashhad University of Medical Sciences
Enrollment
40
Locations
1
Primary Endpoint
Metabolic control
Status
Completed
Last Updated
11 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2007
End Date
September 2008
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amir Moeintaghavi

associate professor of periodontics

Mashhad University of Medical Sciences

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • periodontal improvement after scaling and rootplaning(3 months after treatment)

Study Sites (1)

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