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: May 19, 2014
Last verified: May 2014

October 4, 2007
May 19, 2014
April 2003
July 2016   (final data collection date for primary outcome measure)
Optical Sensor for Photodynamic Detection of Oral Pathology [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00540774 on ClinicalTrials.gov Archive Site
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Optical Sensor for Photodynamic Detection of Oral Pathology
Optical Sensor for Photodynamic Detection of Oral Pathology

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.

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

primary care clinic, community sample

Mouth Diseases
Device: OCT/DOS
OCT/Diffuse Optical Spectroscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
84
July 2016
July 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or Female age 18 years and older

Exclusion Criteria:

  • Age less than 18 years old
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00540774
NIH-OCT-EB-093-07
No
Montana Compton, University of California, Irvine
Montana Compton
  • Beckman Laser Institute University of California Irvine
  • Otolaryngology Medical Clinic,University of California, Irvine
  • Colgate Palmolive
Principal Investigator: Petra Wilder-Smith, DDS,PhD Beckman Laser Institute, University of Calfornia Irvine
University of California, Irvine
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP