Clinical Trial: Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Relationships Between Periodontal Disease and Type 2 Diabetes Mellitus in the Gullah Population and the Effects of Mechanical Periodontal Therapy and Systemic Antibiot

Brief Summary: Our overall hypothesis is that treatment of periodontal disease will produce better diabetes glycemic control (glycated hemoglobin A1c, or HbA1c) and reduced levels of the catalytically active form of matrix metalloproteinase (aMMP-8) in the Gullah African American type 2 diabetes patients living on the Sea Islands of the South Carolina coast. The gingival crevicular fluid (GCF) aMMP-8 levels will be measured through a site-specific, novel noninvasive technique allowing the pathophysiological status of the periodontium tissue to be monitored. The investigators will conduct an interventional study on this population with minimal genetic admixture.

Detailed Summary:
Sponsor: Medical University of South Carolina

Current Primary Outcome:

  • Glycated Hemoglobin A1c [ Time Frame: Change between baseline, 3- and 6-month post-treatment ]
  • Periodontal Pocket Probing Depth (PD) [ Time Frame: Change between baseline, 3- and 6-month post-treatment ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in GCF aMMP-8 levels [ Time Frame: Change between baseline, 3- and 6-month post treatment ]

Original Secondary Outcome: Same as current

Information By: Medical University of South Carolina

Dates:
Date Received: April 18, 2012
Date Started: December 2007
Date Completion:
Last Updated: February 21, 2013
Last Verified: December 2007