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Optical Sensor for Photodynamic Detection of Oral Pathology

This study is currently recruiting participants.
Verified May 2017 by Beckman Laser Institute and Medical Center, University of California, Irvine
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540774
First Posted: October 8, 2007
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Beckman Laser Institute University of California Irvine
Essentialis, Inc.
Orahealth
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
October 4, 2007
October 8, 2007
May 9, 2017
April 2003
July 2018   (Final data collection date for primary outcome measure)
Healthy oral tissue [ Time Frame: up to 12 months ]
Develop a non-invasive tool for the detection, diagnosis and screening of oral pathology and understanding of processes involved in oral pathology
Not Provided
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

Overall objective of this work is to identify optical properties of healthy, diseased, dysplastic and malignant oral tissues, to compare these with conventional diagnostic approaches such as standard of care clinical techniques as well as semi-quantitative histo-pathological assessment and potential biomarkers in oral tissues and fluids to (1) gain a better understanding of processes involved in oral pathology and (2) develop a combined patient specific, non-invasive method for the detection, diagnosis and screening of oral pathology. Thus our goal is to identify and evaluate microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia.

We are recruiting patients with a wide range of oral conditions including plaque, dry mouth, toothache, root canal treatments, gum disease, oral sores, dysplasia and cancer, autoimmune conditions and others as well as healthy control subjects. We will use a range of non-invasive imaging modalities to obtain information on the ways in which the oral health status affects optical properties, and determine means of detecting and quantifying these factors.. Imaging modalities to be utilized include:

  1. Coherence and Doppler Tomography
  2. Laser Speckle Imaging
  3. Various forms of Spectroscopy
  4. Fluorescence

Purpose of the research is to identify optical predictors and biomarkers of oral pathology Hypothesis: microstructural, metabolic, vascular, protein, genomic and metabolomics biomarkers of oral pathology can be used to detect, predict and map oral pathology, especially neoplasia.

Researchers of the Beckman Laser Institute (BLI) have developed many non-invasive imaging modalities for assessment of oral tissue. This protocol will allow data acquisition with these multiple modalities to allow validation of data. Imaging modalities to be utilized include:

  1. Coherence and Doppler Tomography (OCT)
  2. Laser Speckle Imaging (LSI)
  3. Photon Migration Spectroscopy (PMS)
  4. Autofluorescence Imaging

In addition, saliva samples from the patients will be analyzed and the resulting data regarding the dysregulation in the activities of genes, proteins and other molecules will be correlated with findings from different imaging systems with respect to the stage of oral carcinogenesis.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
Study population will be recruited from University of Californis Irvine and Orange Country Dentists.
Mouth Diseases
Device: detection of oral pathology
detection of oral pathology
Oral tissue
detection of oral pathology
Intervention: Device: detection of oral pathology
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
July 2018
July 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or Female age 18 years and older
  • Have oral lesion or not have oral lesion
  • Have condition of dry mouth
  • Have condition of Gum disease
  • Non-smoker

Exclusion Criteria:

  • Age less than 18 years old
  • Advanced gum disease, diseases of oral tissue
  • Untreated cavities
  • Pregnant or breastfeeding
  • Immune compromised individuals
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes
Contact: Montana Compton, R.N 949-824-9265 mocomton@uci.edu
United States
 
 
NCT00540774
NIH/LAMMP-2002-2805
CRO-2009-XER-01-DM ( Other Identifier: COLGATEPALMOLIVE )
No
Not Provided
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Beckman Laser Institute and Medical Center, University of California, Irvine
University of California, Irvine
  • Beckman Laser Institute University of California Irvine
  • Essentialis, Inc.
  • Orahealth
  • National Institutes of Health (NIH)
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Petra Wilder-Smith, DDS,PhD Beckman Laser Institute, University of Calfornia Irvine
University of California, Irvine
May 2017