Impact of Periodontal Disease on Outcomes in Diabetes

Completed

• Conditions: Periodontal Disease; Diabetes Mellitus

• Registration Number: NCT02289066
• Lead Sponsor: University of Nevada, Reno

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-11-07
• Study First Posted: 2014-11-13
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in hemoglobin A1c	At enrollment, 3 months after enrollment and 6 months after enrollment.
biomarkers of inflammation (high sensitivity C - reactive protein and tumor necrosis factor - alpha)	At enrollment, 3 months after enrollment and 6 months after enrollment.
markers of bone turnover (bone specific alkaline phosphatase and C terminal	At enrollment, 3 months after enrollment and 6 months after enrollment.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the relationship between periodontal disease and diabetes control and complications	At enrollment only

Trial Locations

Locations (1)

University of Nevada School of Medicine; 🇺🇸 Las Vegas, Nevada, United States