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Integrated Microfluidic System for Oral Diagnostics

NCT00277745 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2015-12-14

No results posted yet for this study

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 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.

Conditions

  • Healthy
  • Periodontitis

Interventions

DEVICE

miniaturized microfluidic system

Subjects will provide appropriate periodontal treatment as needed.

Sponsors & Collaborators

  • Sandia National Laboratories

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Dental and Craniofacial Research (NIDCR)

    collaborator NIH

  • University of Michigan

    lead OTHER

Principal Investigators

  • William V Giannobile, DDS, DMedSc · Director of MCOHR

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2007-02-28
Completion
2007-06-30

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00277745 on ClinicalTrials.gov