Optical Sensor for Photodynamic Detection of Oral Pathology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Mouth Diseases

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No masking other than an anonymization of data.

Study Groups

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Oral tissue

Imaging of oral structures and pathologies

Group Type OTHER

detection of oral pathology

Intervention Type DEVICE

detection of oral pathology

Interventions

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detection of oral pathology

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Petra E. Wilder-Smith

Professor of Surgery and Director of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Petra Wilder-Smith, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calfornia Irvine

Locations

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Beckman Laser Institute and Medical Clinic

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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20022805

Identifier Type: -

Identifier Source: org_study_id