Status:
COMPLETED
Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Periodontal Disease
Type 2 Diabetes Mellitus
Eligibility:
All Genders
13+ years
Phase:
PHASE4
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...
Detailed Description
Specific Aim 1: To ascertain the rate of periodontal disease progression on poorly controlled Type 2 diabetic Gullah African American patients as compared to well-controlled Gullah African American pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01798225
Start Date
December 1 2007
End Date
January 1 2010
Last Update
October 4 2018
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