Relationship of Periodontal Disease Treatment and Type 2 Diabetes Mellitus in the Gullah Population
|ClinicalTrials.gov Identifier: NCT01798225|
Recruitment Status : Completed
First Posted : February 25, 2013
Results First Posted : October 4, 2018
Last Update Posted : October 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Periodontal Disease Type 2 Diabetes Mellitus||Drug: Placebo Drug: Doxycycline||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||113 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Placebo Comparator: Control
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) pills.
Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.
Other Name: Control Group
Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Doxycycline 100mg x 14 pills)
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798225
|Study Director:||Renata S. Leite||Medical University of South Carolina|