Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics

NCT ID: NCT01252082

Last Updated: 2015-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-09-30

Brief Summary

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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

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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.

Conditions

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Metabolic Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Scalig and Rootplaning

patients will receive scaling and root planing therapy

Group Type ACTIVE_COMPARATOR

Scaling and Rootplaning

Intervention Type PROCEDURE

All patients in the test group receive scaling and rootplaning under local anesthesia

control

patients in control group will not receive periodontal treatment in the time period of the study

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Scaling and Rootplaning

All patients in the test group receive scaling and rootplaning under local anesthesia

Intervention Type PROCEDURE

Other Intervention Names

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test group control group

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amir Moeintaghavi

associate professor of periodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amir Moeintaghavi, DDS.,Ms.

Role: STUDY_CHAIR

Associate professor,Mashhad Dental School, Mashhad University of Medical Sciences

Locations

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Mashhad Dental School, Mashhad University of Medical Sciences

Mashhad, Khorasan Razavi, Iran

Site Status

Countries

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Iran

References

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Moeintaghavi A, Arab HR, Bozorgnia Y, Kianoush K, Alizadeh M. Non-surgical periodontal therapy affects metabolic control in diabetics: a randomized controlled clinical trial. Aust Dent J. 2012 Mar;57(1):31-7. doi: 10.1111/j.1834-7819.2011.01652.x.

Reference Type RESULT
PMID: 22369555 (View on PubMed)

Other Identifiers

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86067

Identifier Type: -

Identifier Source: org_study_id

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