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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
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

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

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 18, 2012
    Last Updated
    October 3, 2018
    Sponsor
    Medical University of South Carolina
    Collaborators
    National Center for Research Resources (NCRR)
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    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

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

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