Integrated Microfluidic System for Oral Diagnostics
Completed
Conditions studied: Healthy, Periodontitis
In brief
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 two types of fluids, gingival crevicular fluid (GCF) and saliva. GCF is the fluid that accumulates between your teeth and gum tissue. The fluids will be collected in three ways: 1. Direct GCF sampling 2. GCF rinse sampling and 3. Whole saliva. A total of 100 adult patients will participate in this study. These subjects will be of two patient populations: 1) diseased population, with active gum disease; and 2) a low-risk disease population, with no active gum disease. Patients will be seen 6 times over the course of the study over a period of approximately 12 months. At each visit the patient will undergo oral fluid collection, as previously described, and thorough examinations of the mouth, including the taking of measurements for study purposes. Patients will also have radiographs taken at baseline, month 6, and end of study visits.
Key facts
- Study ID
- NCT00277745
- Run by
- University of Michigan
- People needed
- 100
- Starts
- 2005-06-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2015-12-14
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Michigan Center for Oral Health Research — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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