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Integrated Microfluidic System for Oral Diagnostics

NCT ID: NCT00277745

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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 (on the order of nanoliters of fluid) and identify biomarkers of disease such as mediators of inflammation (interleukins -1 and -6; C-reactive protein (CRP), and a marker of bone resorption (ICTP). This analysis will aid in the diagnosis of active periodontal (gum) disease as well as diseases involved in systemic inflammation (e.g., cardiovascular disease) or systemic bone loss (osteoporosis). This project will have two specific goals: 1. To validate the ability of the diagnostic to measure the designated mediators from oral fluids; and 2. Determine the ability of the multiplexed format of mediator analysis to predict disease activity (future bone loss) in patients at high and low risk for disease. This proposed feasibility study will then aid in providing the impetus for sample size and other design requirements for larger, more expanded human clinical trial testing and subsequent technology transfer.

Conditions

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Healthy Periodontitis

Keywords

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periodontitis microfluidics saliva diagnostics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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miniaturized microfluidic system

Subjects will provide appropriate periodontal treatment as needed.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sandia National Laboratories

INDUSTRY

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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William Giannobile

William Giannobile, D.D.S., D.Med.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William V Giannobile, DDS, DMedSc

Role: PRINCIPAL_INVESTIGATOR

Director of MCOHR

Locations

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Michigan Center for Oral Health Research

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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. doi: 10.1196/annals.1384.004.

Reference Type BACKGROUND
PMID: 17435142 (View on PubMed)

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. doi: 10.1196/annals.1384.028.

Reference Type BACKGROUND
PMID: 17435132 (View on PubMed)

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/jop.2009.080480.

Reference Type RESULT
PMID: 19254128 (View on PubMed)

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 fluorescence enzyme-linked immunosorbent assay. Clin Vaccine Immunol. 2009 Dec;16(12):1766-73. doi: 10.1128/CVI.00272-09. Epub 2009 Sep 30.

Reference Type RESULT
PMID: 19793900 (View on PubMed)

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. Epub 2011 Mar 15.

Reference Type RESULT
PMID: 21406610 (View on PubMed)

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):113-120. doi: 10.1111/jcpe.12194. Epub 2013 Dec 12.

Reference Type RESULT
PMID: 24303954 (View on PubMed)

Other Identifiers

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U01DE014961-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H03-00003522

Identifier Type: -

Identifier Source: org_study_id