Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics

Metabolic Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252082
• Other study ID #: 86067
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2010
• Last updated: April 7, 2015
• Start date: June 2007
• Est. completion date: September 2008

Study information

• Verified date: April 2015
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Control

Intervention

Procedure:
• Scaling and Rootplaning
All patients in the test group receive scaling and rootplaning under local anesthesia

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad Dental School, Mashhad University of Medical Sciences	Mashhad	Khorasan Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic control	fasting plasma glucose (FPG), HbA1c, TG, TC, high density lipoprotein cholesterol (HDL), and LDL are measured at baseline and 3 months after treatment.	3 months after treatment	No
Secondary	periodontal improvement after scaling and rootplaning	Periodontal parameters (Plaque index, Gingival index, Clinical Attachment level and Probing depth)are Measured at baseline and 3 months after treatment	3 months after treatment	No