Optical Sensor for Photodynamic Detection of Oral Pathology

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

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Key information

Conditions

Mouth Diseases Gingival Diseases Gingivitis Head and Neck Neoplasms Infections Mouth Neoplasms Neoplasms Neoplasms by Site Periodontal Diseases Periodontitis Salivary Gland Diseases Stomatitis Stomatognathic Diseases Xerostomia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beckman Laser Institute and Medical Clinic

Irvine, California, 92612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

detection of oral pathology

Device

detection of oral pathology

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

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

Livionex Inc.
National Cancer Institute (NCI)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Dental and Craniofacial Research (NIDCR)
Orahealth

Registry information

Important dates

Study start: 2003
Primary completion: 2026
Study completion: 2026
First posted: Oct 8, 2007
Registry last updated: Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed