Optical Sensor for Photodynamic Detection of Oral Pathology
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|ClinicalTrials.gov Identifier: NCT00540774|
Recruitment Status : Recruiting
First Posted : October 8, 2007
Last Update Posted : November 2, 2022
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
|Condition or disease||Intervention/treatment||Phase|
|Mouth Diseases||Device: detection of oral pathology||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2500 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Optical Sensor for Photodynamic Detection of Oral Pathology|
|Study Start Date :||April 2003|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||July 2024|
Imaging of oral structures and pathologies
Device: detection of oral pathology
detection of oral pathology
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540774
|Contact: Hanna Kim, MAemail@example.com|
|United States, California|
|Beckman Laser Institute, University of California Irvine||Recruiting|
|Irvine, California, United States, 92612|
|Contact: Hanna Kim, MA 949-824-9265 firstname.lastname@example.org|
|Principal Investigator: Petra Wilder-Smith, DDS,PhD|
|Principal Investigator:||Petra Wilder-Smith, DDS,PhD||Beckman Laser Institute, University of Calfornia Irvine|