Type 2 Diabetes Mellitus Clinical Trial
Official title:
The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 DiabetesS
Type 2 diabetes mellitus (T2DM) has become a significant pandemic with more than 7% of the
population in the United States affected. Moreover, up to one-third of these individuals may
not be aware of the diagnosis and, are not involved in treatment. In the Mexican-American
population, prevalence rates may be up to 50%. Contributing factors such as poor education,
low household income, language barriers and restricted access to medical services may
increase this prevalence. The association between periodontal disease and diabetes has been
well documented; however, interventional studies have resulted in conflicting conclusions on
improvements in glycemic control following periodontal therapy.
Diabetes and periodontal disease share common pathways in pathogenesis, such as their
polygenic nature and immunoregulatory dysfunction. To answer these questions, we, the
investigators, propose this randomized controlled trial designed to elucidate how treatment
of periodontal disease can be used for preventive and therapeutic purposes in a diabetic
population as well as to study the role of IL-1 gene cluster polymorphisms as a risk factor
for the presence of periodontitis in a Hispanic T2DM population. Our central hypothesis is
that the Mexican-American T2DM population in Texas is at risk for an increased presence and
severity of periodontal disease due to the presence of Il-1 gene cluster polymorphisms;
furthermore we suggest that providing non-surgical periodontal therapy to this group will
decrease the bacterial load associated with disease and as a consequence, will improve
glycemic control as measured by HbA1c values. Our long-term goal is to study risk factors
associated with the presence of periodontal disease and to understand how the treatment of
periodontal disease can be used for preventive and therapeutic purposes in a Hispanic type 2
diabetic population.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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