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Optical Sensor for Photodynamic Detection of Oral Pathology

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ClinicalTrials.gov Identifier: NCT00540774
Recruitment Status : Recruiting
First Posted : October 8, 2007
Last Update Posted : November 2, 2022
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
Livionex Inc
Orahealth
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Brief Summary:

Overall objective of this work is to develop better ways of detecting, diagnosing and measuring oral diseases and structures using light and optical approaches. All different areas of the mouth will be imaged, including healthy, diseased, dysplastic and malignant, as well as oral biofilm, and the imaging data compared against conventional diagnostic approaches such clinical and histopathological and molecular evaluations 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 and biofilm. 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 or disease Intervention/treatment Phase
Mouth Diseases Device: detection of oral pathology Not Applicable

Detailed Description:

Purpose of the research is to identify optical predictors and biomarkers of health and disease.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Official Title: Optical Sensor for Photodynamic Detection of Oral Pathology
Study Start Date : April 2003
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mouth Disorders

Arm Intervention/treatment
Oral tissue
Imaging of oral structures and pathologies
Device: detection of oral pathology
detection of oral pathology




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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
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Contact: Hanna Kim, MA 949-824-9265 hhkim3@uci.edu

Locations
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United States, California
Beckman Laser Institute, University of California Irvine Recruiting
Irvine, California, United States, 92612
Contact: Hanna Kim, MA    949-824-9265    hhkim3@uci.edu   
Principal Investigator: Petra Wilder-Smith, DDS,PhD         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Cancer Institute (NCI)
National Institute of Dental and Craniofacial Research (NIDCR)
Livionex Inc
Orahealth
Investigators
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Principal Investigator: Petra Wilder-Smith, DDS,PhD Beckman Laser Institute, University of Calfornia Irvine
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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    
Other Study ID Numbers: 20022805
R44CA265514 ( U.S. NIH Grant/Contract )
T31IR1825 ( Other Grant/Funding Number: California Tobacco-Related Diseases Research Program )
R03EB014852 ( U.S. NIH Grant/Contract )
R01DE022831 ( U.S. NIH Grant/Contract )
LDG ( Other Identifier: Livionex )
OE ( Other Identifier: Oral Essentials )
First Posted: October 8, 2007    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Oral cancer
Oral mucositis
Periodontitis
Dry mouth
Gingivitis
Oral lesions
Dental Hard Tissues
Oral Biofilm
Additional relevant MeSH terms:
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Mouth Diseases
Stomatognathic Diseases