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Trial record 3 of 46 for:    gum disease | NIH

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

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ClinicalTrials.gov Identifier: NCT01798225
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : February 25, 2013
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Medical University of South Carolina

April 18, 2012
February 25, 2013
February 25, 2013
December 2007
January 2010   (Final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
Change in GCF aMMP-8 levels [ Time Frame: Change between baseline, 3- and 6-month post treatment ]
Same as current
Not Provided
Not Provided
 
Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population
The Relationships Between Periodontal Disease and Type 2 Diabetes Mellitus in the Gullah Population and the Effects of Mechanical Periodontal Therapy and Systemic Antibiotics on the Glycemic Control
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Periodontal Disease
  • Type 2 Diabetes Mellitus
  • Drug: Placebo
    Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.
  • Drug: Doxycycline
    Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)
  • Placebo Comparator: Control
    Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills.
    Intervention: Drug: Placebo
  • Experimental: Doxycycline
    Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills)
    Intervention: Drug: Doxycycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
Same as current
January 2010
January 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01798225
P20RR017696-06( U.S. NIH Grant/Contract )
P20RR017696 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Medical University of South Carolina
Medical University of South Carolina
National Center for Research Resources (NCRR)
Study Director: Renata S. Leite Medical University of South Carolina
Medical University of South Carolina
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP