Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Sao Paulo
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Giuseppe Alexandre Romito, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01291875
First received: February 8, 2011
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

The studies that correlate periodontal disease (PD) and diabetes mellitus (DM) suggest that individuals with poor glycemic control are at increased risk for developing infections. Despite being controlled for other important risk factors, diabetic patients are three times more likely to develop PD, and therefore, periodontitis has been proposed as the sixth complication of DM.

Besides the effect of diabetes on DP, the reverse has also been studied over the past 15 years, through the idea that chronic and acute infections can directly affect the tissue resistance to insulin. Recent studies have provided evidence that controlling periodontal infection has an impact on improvement of glycemic control in diabetes mellitus patients. The vascularity of the inflamed periodontal tissue serves as a gateway to inflammatory mediators, pathogenic bacteria and their products into the bloodstream. Some researchers have suggested that periodontal treatment in type 2 diabetes mellitus (DMT2) patients, results in beneficial effect on the level of glycemic control. However, there is no conclusive evidence to support this hypothesis.

This research project aims to determinate the impact of periodontal therapy on metabolic control in DMT2 individuals, and determinate the possible association between periodontal disease and DMT2. For the HbA1c outcome this clinical trial had a sample size calculation estimated at 120 patients. For the inflammatory serum markers this study had a sample size estimated at 22 individuals. Blood samples will be collected for evaluation of Hba1c and inflammatory serum markers. This data will highlight the possible role of periodontal therapy on DMT2 metabolic control.


Condition Intervention
Type 2 Diabetes Mellitus
Periodontal Disease
Procedure: non-surgical periodontal treatment
Procedure: Supragingival biofilm control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Changes in HbA1c and serum inflammatory markers of inflammation after periodontal intervention [ Time Frame: It will be assessed 2, 6 and 12 months after periodontal treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 732
Study Start Date: February 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive periodontal treatment Procedure: non-surgical periodontal treatment
Patients in this group will receive a non surgical periodontal therapy: scaling and root planing of the root surfaces under local analgesia (depending on the severity in one session or two sessions within 2 days). Any tooth that from the baseline examination is defined as hopeless or irrationale to treat will be extracted. After to 2 months re-assessment presenting at least one periodontal site with pocket depth of 6 mm will have additional corrective periodontal therapy.
Active Comparator: Supragingival biofilm control Procedure: Supragingival biofilm control
Control group patients will receive a standard cycle of supra-gingival mechanical instrumentation and polishing in one appointment performed as appropriate by a single clinician using a combination of hand and machine driven (piezoelectric) instrumentation.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject aged over 30 years old
  • Subject diagnosed with T2DM
  • Subject consenting to the study
  • Subject with signs of severe periodontitis (at least 50 periodontal pockets, PPD > 4mm and Bleeding on Probing)

Exclusion Criteria:

  • Pregnancy - Lactation
  • Subject is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit
  • Subject with known HIV or Hepatitis (B, C)
  • Subjects with uncontrolled systemic diseases (cardiovascular diseases including hypertension, liver, pulmonary diseases, end stage renal failure) and/or neoplasm
  • Subjects not capable to provide informed consent
  • Subjects on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291875

Contacts
Contact: Hilana Artese, MDS +55 11 30917833 hilanartese@gmail.com

Locations
Brazil
School of Dentistry - University of São Paulo Recruiting
São Paulo, Brazil, 05508-900
Contact: Giuseppe A Romito, PhD    +55 11 30917833    garomito@usp.br   
Contact: Adriana Foz, MDS    +55 11 30917833    didafoz@uol.com.br   
Principal Investigator: Giuseppe A Romito, PhD         
Sponsors and Collaborators
University of Sao Paulo
Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Giuseppe Alexandre Romito, Chairman of Periodontics Department, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01291875     History of Changes
Other Study ID Numbers: 127/2009
Study First Received: February 8, 2011
Last Updated: February 10, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:
Type 2 Diabetes mellitus
Periodontal Disease
metabolic control
periodontal treatment
inflammatory markers

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Periodontal Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 21, 2014