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

Study Overview

• Status: Recruiting
• Conditions: Mouth Diseases
• Intervention / Treatment: Device: detection of oral pathology

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.

• Study Type: Interventional
• Enrollment (Estimated): 2500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Wakida, PhD; Phone Number: 949-824-4360; Email: nwakida@uci.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92612
      • Recruiting
      • Beckman Laser Institute and Medical Clinic
      • Principal Investigator: Petra Wilder-Smith, DDS, PhD
      • Contact: Nicole Wakida, PhD; Phone Number: 949-824-4360; Email: nwakida@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Oral tissue; Imaging of oral structures and pathologies	Device: detection of oral pathology; detection of oral pathology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthy oral tissue	Develop a non-invasive tool for the detection, diagnosis and screening of oral pathology and understanding of processes involved in oral pathology	up to 12 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); National Institute of Dental and Craniofacial Research (NIDCR); National Institute for Biomedical Imaging and Bioengineering (NIBIB); Orahealth; Livionex Inc.
• Investigators: Principal Investigator: Petra Wilder-Smith, DDS, PhD, University of Calfornia Irvine

Study record dates

Study Major Dates

• Study Start: April 1, 2003
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 4, 2007
• First Submitted That Met QC Criteria: October 4, 2007
• First Posted (Estimated): October 8, 2007

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Periodontitis; Oral cancer; Oral mucositis; Dry mouth; Gingivitis; Oral lesions; Dental Hard Tissues; Oral Biofilm
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases
• Other Study ID Numbers: 20022805; R44CA265514 (U.S. NIH Grant/Contract); T31IR1825 (Other Grant/Funding Number: California Tobacco-Related Diseases Research Program); R03EB014852 (U.S. NIH Grant/Contract); R01DE022831 (U.S. NIH Grant/Contract); LDG (Other Identifier: Livionex); OE (Other Identifier: Oral Essentials); UCI-08-52 (Other Identifier: UCI Chao Family Comprehensive Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No