Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients
Primary Purpose
Type 2 Diabetes Mellitus, Periodontal Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
non-surgical periodontal treatment
Supragingival biofilm control
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes mellitus, Periodontal Disease, metabolic control, periodontal treatment, inflammatory markers
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
Sites / Locations
- School of Dentistry - University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive periodontal treatment
Supragingival biofilm control
Arm Description
Outcomes
Primary Outcome Measures
Changes in HbA1c and serum inflammatory markers of inflammation after periodontal intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT01291875
First Posted
February 8, 2011
Last Updated
March 23, 2020
Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01291875
Brief Title
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
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Periodontal Disease
Keywords
Type 2 Diabetes mellitus, Periodontal Disease, metabolic control, periodontal treatment, inflammatory markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive periodontal treatment
Arm Type
Experimental
Arm Title
Supragingival biofilm control
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal treatment
Intervention Description
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
Intervention Name(s)
Supragingival biofilm control
Intervention Description
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
School of Dentistry - University of São Paulo
City
São Paulo
ZIP/Postal Code
05508-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients
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