ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 46 for:    gum disease | NIH
Previous Study | Return to List | Next Study

Impact of Periodontal Disease on Outcomes in Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02289066
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
University of Nevada, Reno

October 23, 2014
November 13, 2014
December 2, 2015
November 2013
June 2015   (Final data collection date for primary outcome measure)
  • Changes in hemoglobin A1c [ Time Frame: At enrollment, 3 months after enrollment and 6 months after enrollment. ]
  • 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. ]
  • markers of bone turnover (bone specific alkaline phosphatase and C terminal [ Time Frame: At enrollment, 3 months after enrollment and 6 months after enrollment. ]
Same as current
Complete list of historical versions of study NCT02289066 on ClinicalTrials.gov Archive Site
Evaluation of the relationship between periodontal disease and diabetes control and complications [ Time Frame: At enrollment only ]
Same as current
Not Provided
Not Provided
 
Impact of Periodontal Disease on Outcomes in Diabetes
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
University of Nevada School of Medicine (Las Vegas) Internal medicine and endocrinology clinics
  • Periodontal Disease
  • Diabetes Mellitus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
Same as current
June 2015
June 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02289066
1U54GM104944( U.S. NIH Grant/Contract )
1U54GM104944 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Nevada, Reno
University of Nevada, Reno
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Kenneth E Izuora, MD, MBA University of Nevada, Reno
University of Nevada, Reno
November 2015