Non-surgical Periodontal Therapy Effects Metabolic Control in Diabetics

NCT01252082 | Completed Phase 2 DMC

• 1 other identifier: 86067
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Control

Keywords

metabolic control; fasting plasma glucose; glycated hemoglobin

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• periodontal improvement after scaling and rootplaning

  3 months after treatment

Study Arms (2)

Scalig and Rootplaning

ACTIVE COMPARATOR

patients will receive scaling and root planing therapy

Procedure: Scaling and Rootplaning

control

NO INTERVENTION

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

Interventions

Scaling and Rootplaning PROCEDURE

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

Also known as: test group, control group

Scalig and Rootplaning

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Mashhad Dental School, Mashhad University of Medical Sciences

Mashhad, Khorasan Razavi, 91735-984, Iran

Location

Related 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.

  PMID: 22369555 RESULT

MeSH Terms

Interventions

Tooth Exfoliation; Control Groups

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Amir Moeintaghavi, DDS.,Ms.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of periodontics

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: June 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 8, 2015

Record last verified: 2015-04

Locations

IR (1)