Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population
Primary Purpose
Periodontal Disease, Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Placebo
Doxycycline
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Disease focused on measuring Periodontal Disease, Type 2 Diabetes Mellitus, Gullah African Americans
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Doxycycline
Arm Description
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills.
Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills)
Outcomes
Primary Outcome Measures
Glycated Hemoglobin A1c
Glycated Hemoglobin A1c
Periodontal Pocket Probing Depth (PD)
Secondary Outcome Measures
Full Information
NCT ID
NCT01798225
First Posted
April 18, 2012
Last Updated
October 3, 2018
Sponsor
Medical University of South Carolina
Collaborators
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT01798225
Brief Title
Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population
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 Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Center for Research Resources (NCRR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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 patients. The host inflammatory response appears to be the critical determinant for susceptibility and severity of marginal periodontitis especially in systemically compromised individuals13, with diabetic status perhaps increasing host susceptibility to periodontal infection due to impaired immune response14. Patients have been evaluated 6 months to one year prior to periodontal therapy (this evaluation is connected to a previous COBRE project entitled "Epidemiological Study of Periodontal Disease and Diabetes" by Dr. J. Fernandes). A reevaluation will be made at the time of periodontal therapy. Clinical periodontal parameters and HbA1c levels will be compared.
Specific Aim 2: To assess the effects of successful periodontal therapy on the level of glycemic control in this Gullah African American population. Authors addressing whether the treatment of periodontitis or other infections of the oral cavity can improve glycemic control in diabetic patients report contradictory results. We will treat periodontal patients with mechanical therapy (scaling and root planning) and oral hygiene instruction, with or without systemic antibiotic administration (Table 1). The HbA1c, fasting glucose and clinical periodontal parameters will be evaluated prior to the periodontal intervention, and at 3 and 6 months after therapy. We plan to continue to recruit, enroll and assess new patients from the Gullah African American community living on the Sea Islands of the South Carolina coast for future research projects
Specific Aim 3: To assess the concentration of the catalytically active form of MMP-8 at baseline (prior to periodontal intervention) and at 3 and 6 months later. Polymorphonuclear (PMN) leukocyte-derived MMP-8 is predominantly present in periodontitis-affected GCF9,15-16. Analysis of GCF for aMMP-8 could provide a novel useful noninvasive technique to assess and monitor the pathophysiological status of the periodontium tissue in a site-specific manner9-10.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease, Type 2 Diabetes Mellitus
Keywords
Periodontal Disease, Type 2 Diabetes Mellitus, Gullah African Americans
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills.
Arm Title
Doxycycline
Arm Type
Experimental
Arm Description
Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control Group
Intervention Description
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
Intervention Group
Intervention Description
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 Measure Information:
Title
Glycated Hemoglobin A1c
Description
Glycated Hemoglobin A1c
Time Frame
Change between baseline to 6-month post-treatment
Title
Periodontal Pocket Probing Depth (PD)
Time Frame
Change between baseline to 6-month post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renata S. Leite
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population
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