Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Feb 2011
Longer than P75 for not_applicable type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 8, 2011
CompletedFirst Posted
Study publicly available on registry
February 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 25, 2020
March 1, 2020
3 years
February 8, 2011
March 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in HbA1c and serum inflammatory markers of inflammation after periodontal intervention
It will be assessed 2, 6 and 12 months after periodontal treatment
Study Arms (2)
Intensive periodontal treatment
EXPERIMENTALSupragingival biofilm control
ACTIVE COMPARATORInterventions
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.
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 Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- Federal University of São Paulocollaborator
Study Sites (1)
School of Dentistry - University of São Paulo
São Paulo, 05508-900, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman of Periodontics Department
Study Record Dates
First Submitted
February 8, 2011
First Posted
February 9, 2011
Study Start
February 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2016
Last Updated
March 25, 2020
Record last verified: 2020-03