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

Tracking Information

First Received Date ^ICMJE

October 4, 2007

Last Updated Date

January 24, 2013

Start Date ^ICMJE

April 2003

Estimated Primary Completion Date

July 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00540774 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Optical Sensor for Photodynamic Detection of Oral Pathology

Official Title ^ICMJE

Optical Sensor for Photodynamic Detection of Oral Pathology

Brief Summary

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.

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

primary care clinic, community sample

Condition ^ICMJE

Mouth Diseases

Intervention ^ICMJE

Device: OCT/DOS

OCT/Diffuse Optical Spectroscopy

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2015

Estimated Primary Completion Date

July 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or Female age 18 years and older

Exclusion Criteria:

Age less than 18 years old

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00540774

Other Study ID Numbers ^ICMJE

NIH-OCT-EB-093-07

Has Data Monitoring Committee

Responsible Party

Montana Compton, University of California, Irvine

Study Sponsor ^ICMJE

Montana Compton

Collaborators ^ICMJE

Beckman Laser Institute University of California Irvine
Otolaryngology Medical Clinic,University of California, Irvine
Colgate Palmolive

Investigators ^ICMJE

Principal Investigator:

Petra Wilder-Smith, DDS,PhD

Beckman Laser Institute, University of Calfornia Irvine

Information Provided By

University of California, Irvine

Verification Date

January 2013

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

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