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NCT01128374 · ClinicalTrials.gov registry record · NA
The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 Diabetes
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- NA
- Development phase
- 134
- Enrollment target
NCT01128374 is a NA study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 134 participants.
The verdict
NCT01128374, a NA study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- NA
- Development phase
- 134 participants
- Enrollment target
Study Summary
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.
Interventions
- PROCEDURE Periodontal Scaling and root planing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01128374
The ClinicalTrials.gov registry entry for NCT01128374 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 134 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Periodontal Scaling and root planing is the first listed.
NCT01128374 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01128374 about?
NCT01128374 is a clinical study titled "The Effect of Non-Surgical Periodontal Therapy on Glycemic Control and Bacterial Levels in a Mexican-American Population With Type 2 Diabetes". 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 rat...
What is the current status of trial NCT01128374?
This trial is currently completed. It is a NA study. The enrollment target is 134 participants. The study started on 2010-06. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01128374?
The interventions under investigation include: Periodontal Scaling and root planing (PROCEDURE).
Who is sponsoring clinical trial NCT01128374?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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