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Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics

Sponsor
Mashhad University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01252082
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
15
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 :
Jun 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Sep 1, 2008

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Metabolic control [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amir Moeintaghavi, associate professor of periodontics, Mashhad University of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT01252082
    Other Study ID Numbers:
    • 86067
    First Posted:
    Dec 2, 2010
    Last Update Posted:
    Apr 8, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Amir Moeintaghavi, associate professor of periodontics, Mashhad University of Medical Sciences
    metabolic control
    fasting plasma glucose
    glycated hemoglobin

    Study Results

    No Results Posted as of Apr 8, 2015