Clinical trial NCT01291875: Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients
Official title: Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Periodontal Disease
Keywords: Type 2 Diabetes mellitus
Periodontal Disease
metabolic control
periodontal treatment
inflammatory markers
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
First posted: 2011-02-09
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Changes in HbA1c and serum inflammatory markers of inflammation after periodontal intervention
timeFrame: It will be assessed 2, 6 and 12 months after periodontal treatment
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: School of Dentistry - University of São Paulo
Study officials:
References: