Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Disease Periodontal Diseases Stomatognathic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry - University of São Paulo

São Paulo, 05508-900, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-surgical periodontal treatment

Procedure

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.

Supragingival biofilm control

Procedure

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 outcomes

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

Federal University of São Paulo

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2016
First posted: Feb 9, 2011
Registry last updated: Mar 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed