Optical Sensor for Photodynamic Detection of Oral Pathology

Study Overview
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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: Coherence and Doppler Tomography Laser Speckle Imaging Various forms of Spectroscopy 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: 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.

Official Title
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Optical Sensor for Photodynamic Detection of Oral Pathology

Conditions
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Mouth Diseases

Intervention / Treatment
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* Device: detection of oral pathology


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oral tissue<br>Imaging of oral structures and pathologies | Device: detection of oral pathology<br>* detection of oral pathology<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral cancer, Oral mucositis, Periodontitis, Dry mouth, Gingivitis, Oral lesions, Dental Hard Tissues, Oral Biofilm