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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
  Purpose

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

Condition Intervention
Mouth Diseases Device: detection of oral pathology

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:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: April 2003
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Oral tissue
detection of oral pathology
Device: detection of oral pathology
detection of oral pathology

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population will be recruited from University of Californis Irvine and Orange Country Dentists.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540774


Contacts
Contact: Montana Compton, R.N 949-824-9265 mocomton@uci.edu

Locations
United States, California
Beckman Laser Institute, University of California Irvine Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, R.N    949-824-9265    mocomton@uci.edu   
Principal Investigator: Petra Wilder-Smith, DDS,PhD         
Sub-Investigator: Montana Compton, RN         
Sponsors and Collaborators
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)
Investigators
Principal Investigator: Petra Wilder-Smith, DDS,PhD Beckman Laser Institute, University of Calfornia Irvine
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, Petra Wilder-Smith, DDS., PhD., Director of Dentistry, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540774     History of Changes
Other Study ID Numbers: NIH/LAMMP-2002-2805
CRO-2009-XER-01-DM ( Other Identifier: COLGATEPALMOLIVE )
First Submitted: October 4, 2007
First Posted: October 8, 2007
Last Update Posted: May 9, 2017
Last Verified: May 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
oral cancer
oral mucositis
oral stomatitis
Dry mouth
Gingivitis

Additional relevant MeSH terms:
Mouth Diseases
Stomatognathic Diseases