Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus; Periodontal Disease
MeSH terms: Periodontal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    


Intervention name(s): non-surgical periodontal treatment; Supragingival biofilm control
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 2 Diabetes mellitus; Periodontal Disease; metabolic control; periodontal treatment; inflammatory markers