ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 43 for:    gum disease AND Periodontal | NIH
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Periodontal Disease Type 2 Diabetes Mellitus Drug: Placebo Drug: Doxycycline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Antibiotics on the Glycemic Control
Study Start Date : December 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease

Arm Intervention/treatment
Placebo Comparator: Control
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills.
Drug: Placebo
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.

Experimental: Doxycycline
Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 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)




Primary Outcome Measures :
  1. Glycated Hemoglobin A1c [ Time Frame: Change between baseline, 3- and 6-month post-treatment ]
  2. Periodontal Pocket Probing Depth (PD) [ Time Frame: Change between baseline, 3- and 6-month post-treatment ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798225


Sponsors and Collaborators
Medical University of South Carolina
National Center for Research Resources (NCRR)
Investigators
Study Director: Renata S. Leite Medical University of South Carolina

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01798225     History of Changes
Other Study ID Numbers: P20RR017696-06 ( U.S. NIH Grant/Contract )
P20RR017696 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: December 2007

Keywords provided by Medical University of South Carolina:
Periodontal Disease
Type 2 Diabetes Mellitus
Gullah African Americans

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Anti-Bacterial Agents
Doxycycline
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents