Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01291875
Recruitment Status : Unknown
Verified February 2014 by Giuseppe Alexandre Romito, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : February 9, 2011
Last Update Posted : February 12, 2014
Federal University of São Paulo
Information provided by (Responsible Party):
Giuseppe Alexandre Romito, University of Sao Paulo

Brief Summary:

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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Periodontal Disease Procedure: non-surgical periodontal treatment Procedure: Supragingival biofilm control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 732 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : February 2011
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

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Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01291875

Contact: Hilana Artese, MDS +55 11 30917833

School of Dentistry - University of São Paulo Recruiting
São Paulo, Brazil, 05508-900
Contact: Giuseppe A Romito, PhD    +55 11 30917833   
Contact: Adriana Foz, MDS    +55 11 30917833   
Principal Investigator: Giuseppe A Romito, PhD         
Sponsors and Collaborators
University of Sao Paulo
Federal University of São Paulo

Responsible Party: Giuseppe Alexandre Romito, Chairman of Periodontics Department, University of Sao Paulo Identifier: NCT01291875     History of Changes
Other Study ID Numbers: 127/2009
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: February 2014

Keywords provided by Giuseppe Alexandre Romito, 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
Gingival Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases