Optical Sensor for Photodynamic Detection of Oral Pathology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,004
- Locations
- 2
- Primary Endpoint
- Healthy oral tissue
Study 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:
- Coherence and Doppler Tomography
- Laser Speckle Imaging
- Various forms of Spectroscopy
- 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:
- Coherence and Doppler Tomography (OCT)
- Laser Speckle Imaging (LSI)
- Photon Migration Spectroscopy (PMS)
- 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
No masking other than an anonymization of data.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 (Device)
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Petra E. Wilder-Smith
Professor of Surgery and Director of Dentistry
University of California, Irvine