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

NCT01798225 | Completed Phase 4 Results

• 2 other identifiers: P20RR017696-06P20RR017696
• Study Type: interventional
• Target: 113
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Disease; Type 2 Diabetes Mellitus

Keywords

Periodontal Disease; Type 2 Diabetes Mellitus; Gullah African Americans

Outcome Measures

Primary Outcomes (2)

• Glycated Hemoglobin A1c

  Glycated Hemoglobin A1c

  Change between baseline to 6-month post-treatment

• Periodontal Pocket Probing Depth (PD)

  Change between baseline to 6-month post-treatment

Study Arms (2)

Control

PLACEBO COMPARATOR

Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills.

Drug: Placebo

Doxycycline

EXPERIMENTAL

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

Drug: Doxycycline

Interventions

Placebo DRUG

Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.

Also known as: Control Group

Control

Doxycycline DRUG

Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)

Also known as: Intervention Group

Doxycycline

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gullah African Americans;
• With type 2 diabetes mellitus defined according to the American Diabetes Association criteria;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Center for Research Resources (NCRR): collaborator

MeSH Terms

Conditions

Periodontal Diseases; Diabetes Mellitus, Type 2

Interventions

Control Groups; Doxycycline

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Renata Leite
• Organization: Medical University of South Carolina

leiter@musc.edu

843-792-3908

Study Officials

• Renata S. Leite

  Medical University of South Carolina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: February 25, 2013
• Study Start: December 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 4, 2018
• Results First Posted: October 4, 2018

Record last verified: 2018-10