Optical Sensor Detection for Oral Diseases
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Tomography2. Laser Speckle Imaging3. Various forms of Spectroscopy4. Fluorescence
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
Is the optical sensor detection for oral diseases safe for humans?
How is the Optical Sensor Detection for Oral Diseases treatment different from other treatments for oral diseases?
This treatment is unique because it uses optical sensors to detect oral diseases noninvasively, providing real-time, high-resolution images without the need for ionizing radiation. It offers a patient-friendly and repeatable method that can quickly identify changes in oral tissues, potentially improving early diagnosis and management of oral conditions.56789
What data supports the effectiveness of the treatment for detecting oral diseases using optical sensors?
Research shows that optical diagnostic tools, like fluorescence spectroscopy, are effective in detecting early signs of oral diseases. These tools are non-invasive, provide real-time results, and have been shown to accurately identify oral lesions, which can help in early diagnosis and treatment.125810
Who Is on the Research Team?
Petra Wilder-Smith, DDS, PhD
Principal Investigator
University of Calfornia Irvine
Are You a Good Fit for This Trial?
This trial is for adults over 18, both smokers and non-smokers, with various oral conditions like dry mouth, gum disease, or lesions. It's also open to healthy individuals as controls. People under 18, those with advanced gum disease or untreated cavities, pregnant or breastfeeding women, and immune-compromised individuals cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging and Data Collection
Participants undergo non-invasive imaging using modalities such as Coherence and Doppler Tomography, Laser Speckle Imaging, Photon Migration Spectroscopy, and Autofluorescence Imaging. Saliva samples are also collected for analysis.
Follow-up
Participants are monitored for safety and effectiveness of the imaging modalities and data correlation with oral pathology stages.
What Are the Treatments Tested in This Trial?
Interventions
- Detection of Oral Pathology
Detection of Oral Pathology is already approved in China, United States, European Union for the following indications:
- Oral leukoplakia
- Oral squamous cell carcinoma
- Actinic keratosis
- Barrett's esophagus
- Basal cell carcinoma
- Oral leukoplakia
- Oral squamous cell carcinoma
- Actinic keratosis
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor
Livionex Inc.
Industry Sponsor
Beckman Laser Institute University of California Irvine
Collaborator
Orahealth
Collaborator
Livionex Inc
Collaborator
National Institutes of Health (NIH)
Collaborator
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
National Cancer Institute (NCI)
Collaborator
National Institute of Dental and Craniofacial Research (NIDCR)
Collaborator