Optical Sensor for Photodynamic Detection of Oral Pathology

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Mouth Diseases

Clinical Trial Details

NCT number	NCT00540774
Study type	Interventional
Source	University of California, Irvine
Contact	Nicole Wakida, PhD
Phone	949-824-4360
Email	nwakida@uci.edu
Status	Recruiting
Phase	N/A
Start date	April 2003
Completion date	December 2028

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.