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Clinical Trials/NCT00540774
NCT00540774
Completed
Not Applicable

Optical Sensor for Photodynamic Detection of Oral Pathology

University of California, Irvine2 sites in 1 country1,004 target enrollmentApril 1, 2003

Overview

Phase
Not Applicable
Intervention
detection of oral pathology
Conditions
Mouth Diseases
Sponsor
University of California, Irvine
Enrollment
1004
Locations
2
Primary Endpoint
Healthy oral tissue
Status
Completed
Last Updated
23 days ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2003
End Date
March 3, 2026
Last Updated
23 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Petra E. Wilder-Smith

Professor of Surgery and Director of Dentistry

University of California, Irvine

Eligibility 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

Arms & Interventions

Oral tissue

Imaging of oral structures and pathologies

Intervention: detection of oral pathology

Outcomes

Primary Outcomes

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

Study Sites (2)

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