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NCT number NCT00540774
Study type Observational
Source University of California, Irvine
Contact Montana Compton, R.N
Phone 949-824-9265
Email mocomton@uci.edu
Status Recruiting
Phase N/A
Start date April 2003
Completion date July 2018

Clinical Trial Summary

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


Clinical Trial 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.


Study Design


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