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Optical Sensor for Photodynamic Detection of Oral Pathology

Optical Sensor for Photodynamic Detection of Oral Pathology

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00540774
Enrollment
1004
Registered
2007-10-08
Start date
2003-04-01
Completion date
2026-03-03
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mouth Diseases

Keywords

Oral cancer, Oral mucositis, Periodontitis, Dry mouth, Gingivitis, Oral lesions, Dental Hard Tissues, Oral Biofilm

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: 1. Coherence and Doppler Tomography 2. Laser Speckle Imaging 3. Various forms of Spectroscopy 4. 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: 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.

Interventions

DEVICEdetection of oral pathology

detection of oral pathology

Sponsors

University of California, Irvine
Lead SponsorOTHER
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
CollaboratorNIH
National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
Livionex Inc.
CollaboratorINDUSTRY
Orahealth
CollaboratorUNKNOWN
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

No masking other than an anonymization of data.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Healthy oral tissueup to 12 monthsDevelop a non-invasive tool for the detection, diagnosis and screening of oral pathology and understanding of processes involved in oral pathology

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPetra Wilder-Smith, DDS, PhD

University of Calfornia Irvine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026