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Trial record 3 of 49 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
Results First Posted : October 4, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Medical University of South Carolina

Tracking Information
First Submitted Date  ICMJE April 18, 2012
First Posted Date  ICMJE February 25, 2013
Results First Submitted Date May 4, 2017
Results First Posted Date October 4, 2018
Last Update Posted Date October 4, 2018
Study Start Date  ICMJE December 2007
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • Glycated Hemoglobin A1c [ Time Frame: Change between baseline to 6-month post-treatment ]
    Glycated Hemoglobin A1c
  • Periodontal Pocket Probing Depth (PD) [ Time Frame: Change between baseline to 6-month post-treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
  • 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 ]
Change History Complete list of historical versions of study NCT01798225 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
Change in GCF aMMP-8 levels [ Time Frame: Change between baseline, 3- and 6-month post treatment ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Periodontal Disease
  • Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Placebo
    Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.
    Other Name: Control Group
  • 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)
    Other Name: Intervention Group
Study Arms
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2013)
113
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01798225
Other Study ID Numbers  ICMJE P20RR017696-06( U.S. NIH Grant/Contract )
P20RR017696 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE National Center for Research Resources (NCRR)
Investigators  ICMJE
Study Director: Renata S. Leite Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date October 2018

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