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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Doxycycline

Criteria

Inclusion Criteria:

• Gullah African Americans;

• With type 2 diabetes mellitus defined according to the American Diabetes Association criteria;

Other inclusion criteria are presented under each Specific Aim:

• AIM 1: Participants who have received oral, dental, periodontal, diabetes and genotype assessment through enrollment in Dr. J. Fernandes' COBRE project.

• AIM 2 and 3: Participants with severe chronic periodontitis, as defined by at least one tooth surface with probing depth (PD)≥5mm.

Exclusion Criteria:

• Severe concurrent illnesses / conditions that would limit their daily life or require extensive systemic treatment, such as malignancy, severe cardiovascular disease, organ transplant, or inadequate understanding due to mental disorders;

• Finger stick blood glucose measurement of more than 350mg/dl or less than 70mg/dl after second measurement;

• Systolic blood pressure of more than 180mm Hg or diastolic pressure of more than 100mm Hg;

• Fasting serum C-peptide < 1ng/ml (documentation or test);

• Serum creatinine ≥ 1.6mg/dl;

• Abnormal hepatic function;

• Hemoglobinopathy (sickle cell trait/hemolytic anemia) interfering with HbA1c monitoring;

• Other underlying illness/conditions which, in the doctor's judgment, may prevent patient from adherence to the study protocol;

• Unwillingness to sign the informed consent form or enter the study;

• Pregnant women;

• Patients in need of antibiotic prophylaxis prior to dental procedures or patients that have been treated with any kind of antibiotics in the past 3 months.