Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients
Recruitment status was Recruiting
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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. This clinical trial will have 120 DMT2 patients and all of them will receive periodontal treatment. Blood samples will be collected for glucose. These data will highlight the possible role of periodontal therapy on DMT2 metabolic control.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus Periodontal Disease |
Procedure: non-surgical and surgical periodontal treatment Procedure: Supra gingival scaling and polishing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
- Changes in HbA1c level after periodontal treatment [ Time Frame: It will be assessed 2, 6 and 12 months after periodontal treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intensive periodontal treatment |
Procedure: non-surgical and surgical periodontal treatment
Patients in this group will receive a non surgical regimen of 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 the 2 months re-assessment individuals in this group if presenting with at least one periodontal pocket of 6 mm in depth will undergo additional corrective periodontal therapy.
|
| Active Comparator: Control periodontal treatment |
Procedure: Supra gingival scaling and polishing
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 |
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| Contact: Hilana Artese, MDS | +55 11 30917833 | hilanartese@gmail.com |
| 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 | |
More Information
No publications provided
| Responsible Party: | Giuseppe Alexandre Romito, University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01291875 History of Changes |
| Other Study ID Numbers: | 127/2009 |
| Study First Received: | February 8, 2011 |
| Last Updated: | February 8, 2011 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by University of Sao Paulo:
|
Type 2 Diabetes mellitus Periodontal Disease metabolic control periodontal treatment |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Periodontal Diseases Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Mouth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013