Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population
Condition: Periodontal Disease; Type 2 Diabetes Mellitus
MeSH terms: Periodontal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Doxycycline
Intervention description: Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.; Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 113.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No
Keywords: Periodontal Disease; Type 2 Diabetes Mellitus; Gullah African Americans

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.
    

Eligibility 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.