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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02289066
Other study ID # 1U54GM104944
Secondary ID 1U54GM104944
Status Completed
Phase N/A
First received October 23, 2014
Last updated November 30, 2015
Start date November 2013
Est. completion date June 2015

Study information

Verified date November 2015
Source University of Nevada, Reno
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study examines how periodontal disease affects the complications of diabetes and how treatment for periodontal disease affects biomarkers associated with the complications of diabetes.


Description:

The goal is to look for predictive factors of poor oral health and the impact of poor oral health on the complications of diabetes. The prevalence of periodontal disease among patients with diabetes is higher than in the general population. Periodontal disease is associated with dental loss and increased systemic inflammation which is associated with cardiovascular and bone disease. However, current evidence that treatment of POD will result in improvement of outcomes in patients with diabetes is mixed. Identifying patterns of disease and following biomarkers in patients with diabetes and periodontal disease will answer some of the questions and result in more appropriate recommendations and interventions with reduction in morbidity, mortality and healthcare cost.

This study will be conducted using a cross-sectional design. Investigators will survey 200 consecutive patients with diabetes during routine clinic visits using a questionnaire. Investigators will collect data on demographic information, socio-economic status, oral health status/care, diabetes history (duration, control and complications) and bone health. A subgroup of 24 participants with survey responses suggestive of periodontal disease will be selected to receive treatment for periodontal disease. We will measure their hemoglobin A1c and biomarkers before and after treatment and will compare their levels for changes with treatment. Investigators will analyze collected data using test of proportions, Student's t-test and multivariate regression analyses.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

All patients 18 years or older with diabetes for more than 2 years who present for their regular clinic visit will be eligible for inclusion in the survey part of the study. Further criteria for enrollment into the subgroup (n = 24) will include; Inclusion criteria

- Answers on the questionnaire suggesting POD or gingivitis.

- At least 16 teeth in place

- On a stable treatment for their diabetes

- Hemoglobin A1c between 6 and 10

Exclusion Criteria:

- Treatment with anti-inflammatory medications

- Cigarette smoking

- Treatment with thiazolidinediones

- Previous diagnosis of osteoporosis or treatment for osteoporosis with FDA approved agents.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Locations

Country Name City State
United States University of Nevada School of Medicine Las Vegas Nevada

Sponsors (2)

Lead Sponsor Collaborator
University of Nevada, Reno National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

References & Publications (2)

1. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.

Boyle JP, Thompson TJ, Gregg EW, Barker LE, Williamson DF. Projection of the year 2050 burden of diabetes in the US adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. Popul Health Metr. 2010 Oct 22;8:29. doi: 10.1186/1478-7954-8-29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in hemoglobin A1c At enrollment, 3 months after enrollment and 6 months after enrollment. No
Primary biomarkers of inflammation (high sensitivity C - reactive protein and tumor necrosis factor - alpha) At enrollment, 3 months after enrollment and 6 months after enrollment. No
Primary markers of bone turnover (bone specific alkaline phosphatase and C terminal At enrollment, 3 months after enrollment and 6 months after enrollment. No
Secondary Evaluation of the relationship between periodontal disease and diabetes control and complications At enrollment only No
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