Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients

NCT ID: NCT01291875

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2016-02-29

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.

Conditions

Type 2 Diabetes Mellitus; Periodontal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive periodontal treatment

Group Type: EXPERIMENTAL

non-surgical periodontal treatment

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Supragingival biofilm control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Alexandre Romito

Chairman of Periodontics Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

School of Dentistry - University of São Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

127/2009

Identifier Type: -

Identifier Source: org_study_id