Healthy Clinical Trial
Official title:
Integrated Microfluidic System for Oral Diagnostics
Verified date | December 2015 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 2007 |
Est. primary completion date | February 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Michigan Center for Oral Health Research | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH), Sandia National Laboratories |
United States,
Herr AE, Hatch AV, Giannobile WV, Throckmorton DJ, Tran HM, Brennan JS, Singh AK. Integrated microfluidic platform for oral diagnostics. Ann N Y Acad Sci. 2007 Mar;1098:362-74. Review. — View Citation
Kinney JS, Morelli T, Braun T, Ramseier CA, Herr AE, Sugai JV, Shelburne CE, Rayburn LA, Singh AK, Giannobile WV. Saliva/pathogen biomarker signatures and periodontal disease progression. J Dent Res. 2011 Jun;90(6):752-8. doi: 10.1177/0022034511399908. Ep — View Citation
Kinney JS, Morelli T, Oh M, Braun TM, Ramseier CA, Sugai JV, Giannobile WV. Crevicular fluid biomarkers and periodontal disease progression. J Clin Periodontol. 2014 Feb;41(2):113-20. doi: 10.1111/jcpe.12194. Epub 2013 Dec 12. — View Citation
Kinney JS, Ramseier CA, Giannobile WV. Oral fluid-based biomarkers of alveolar bone loss in periodontitis. Ann N Y Acad Sci. 2007 Mar;1098:230-51. Review. — View Citation
Ramseier CA, Kinney JS, Herr AE, Braun T, Sugai JV, Shelburne CA, Rayburn LA, Tran HM, Singh AK, Giannobile WV. Identification of pathogen and host-response markers correlated with periodontal disease. J Periodontol. 2009 Mar;80(3):436-46. doi: 10.1902/jo — View Citation
Sweier DG, Shelburne PS, Giannobile WV, Kinney JS, Lopatin DE, Shelburne CE. Immunoglobulin G (IgG) class, but Not IgA or IgM, antibodies to peptides of the Porphyromonas gingivalis chaperone HtpG predict health in subjects with periodontitis by a fluores — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proof of principle study to determine ability of device to predict disease activity in patients at high and low risk for disease. | 2 years | No |
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