Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients
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|ClinicalTrials.gov Identifier: NCT01291875|
Recruitment Status : Unknown
Verified February 2014 by Giuseppe Alexandre Romito, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted : February 9, 2011
Last Update Posted : February 12, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Periodontal Disease||Procedure: non-surgical periodontal treatment Procedure: Supragingival biofilm control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||732 participants|
|Intervention Model:||Parallel Assignment|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||February 2014|
|Experimental: Intensive periodontal treatment||
Procedure: 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.
|Active Comparator: Supragingival biofilm control||
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291875
|Contact: Hilana Artese, MDS||+55 11 email@example.com|
|School of Dentistry - University of São Paulo||Recruiting|
|São Paulo, Brazil, 05508-900|
|Contact: Giuseppe A Romito, PhD +55 11 30917833 firstname.lastname@example.org|
|Contact: Adriana Foz, MDS +55 11 30917833 email@example.com|
|Principal Investigator: Giuseppe A Romito, PhD|