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Optical Sensor for Photodynamic Detection of Oral Pathology

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Otolaryngology Medical Clinic,University of California, Irvine
Colgate Palmolive
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540774
First received: October 4, 2007
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

At Beckman Laser Institute, University of California, Irvine, we have developed diagnostic device call frequency-domain photon migration(FDPM and Optical Coherence tomography (OCT).

OCT is an imaging technique capable of performing high-resolution,cross-sectional imaging. OCT enables real-time, in situ visualization of tissue microstructure without the need to excise and process the specimen as required for conventional biopsy and histopathology.

FDPM technique measured in vivo using the the wavelength-dependent behavior of absorption and scattering.

  • Absorption measurements determine the water concentration, oxyhemoglobin concentration, deoxyhemoglobin concentration,total hemoglobin concentration, oxygen saturation, and fat percentage.
  • Scattering measurements determine the cell volume fraction,average cell size, and tissue structural heterogeneity.

Condition Intervention
Mouth Diseases
 Device: OCT/DOS

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Sensor for Photodynamic Detection of Oral Pathology

Resource links provided by NLM:

MedlinePlus related topics: Mouth Disorders
U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Optical Sensor for Photodynamic Detection of Oral Pathology [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: April 2003
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: OCT/DOS
    OCT/Diffuse Optical Spectroscopy
Detailed Description:

This study determined the change in the optical properties of oral tissues, and combine these with conventional semiquantitative histopathological to have information of the oral pathology.

The study to determine the absorption and reflection spectra of healthy and pathological oral tissues and to correlate these with oral pathology. Rationale is that tissue architecture, components, metabolic processes and vasculature change with the onset and progression of pathology. Each of these factors has optical signatures that detected non-invasively.

A soft small fiberoptic pen shape sensor with fiberoptic-based spectrographic system place in selective oral cavity. Six measurements and image will be taking within approximate 5 minutes.

The possible risks and/or discomforts associated with the procedures described in this study include some discomfort of having the optical tool placed in the mouth the device will be removed immediately. There may also be risks to participating that are currently unforeseeable.

There are no direct benefit but potential benefit to society by helping to develop new tools for early detection, monitoring, screening for oral pathology

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic, community sample

Criteria

Inclusion Criteria:

  • Male or Female age 18 years and older

Exclusion Criteria:

  • Age less than 18 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00540774

Locations
United States, California
Beckman Laser Institute, University of California Irvine
Irvine, California, United States, 92612
UCI student health center
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Otolaryngology Medical Clinic,University of California, Irvine
Colgate Palmolive
Investigators
Principal Investigator: Petra Wilder-Smith, DDS,PhD Beckman Laser Institute, University of Calfornia Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540774     History of Changes
Other Study ID Numbers: NIH-OCT-EB-093-07
Study First Received: October 4, 2007
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
oral cancer
oral mucositis
oral stomatitis

Additional relevant MeSH terms:
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 19, 2013