Status:
COMPLETED
Integrated Microfluidic System for Oral Diagnostics
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Sandia National Laboratories
National Institutes of Health (NIH)
Conditions:
Healthy
Periodontitis
Eligibility:
All Genders
18-80 years
Brief Summary
This study is being conducted to test the ability and accuracy of a new instrument in the diagnosis of periodontitis (gum disease) by using fluids from the mouth. The diagnosis instrument will test tw...
Detailed Description
The ultimate goal of this investigation is to validate the ability of the prototype platform (miniaturized microfluidic device that can rapidly (within 15 minutes) measure small volumes of oral fluids...
Eligibility Criteria
Inclusion
- Must possess at least 20 teeth and not have received periodontal treatment or antibiotic-related therapy for medical or dental reasons 3 months prior to study inclusion.
- Low-risk inclusion: \< 3 mm of attachment loss, no pockets \> 4 mm, possess no radiographic bone loss, and \< 20 sites with bleeding on probing (BOP). Low-risk cohort will be comprised of at least \> 50% of the subjects above age 35 in order to exam low risk patients in other age strata (so as to decrease potential bias towards a younger population in the low risk cohort).
- Disease-susceptible inclusion: Exhibit at least 4 sites with evidence of radiographic bone loss, mean attachment loss \> 3 mm, pocket depths (PD) \> 4 mm and BOP.
Exclusion
- Long-term use of medications known to affect periodontal status such as anti-inflammatory drugs (NSAIDS and aspirins)
- History of metabolic bone diseases such as rheumatoid arthritis or post-menopausal osteoporosis.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00277745
Start Date
June 1 2005
End Date
June 1 2007
Last Update
December 14 2015
Active Locations (1)
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1
Michigan Center for Oral Health Research
Ann Arbor, Michigan, United States, 48106