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Completed

NCT Number: NCT02289066

Impact of Periodontal Disease on Outcomes in Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nevada School of Medicine

Las Vegas, Nevada, 89102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Changes in hemoglobin A1c

    Time frame: At enrollment, 3 months after enrollment and 6 months after enrollment.

  2. biomarkers of inflammation (high sensitivity C - reactive protein and tumor necrosis factor - alpha)

    Time frame: At enrollment, 3 months after enrollment and 6 months after enrollment.

  3. markers of bone turnover (bone specific alkaline phosphatase and C terminal

    Time frame: At enrollment, 3 months after enrollment and 6 months after enrollment.

Secondary outcomes

  1. Evaluation of the relationship between periodontal disease and diabetes control and complications

    Time frame: At enrollment only

Sponsors and collaborators

Lead sponsor

University of Nevada, Reno

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2014
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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