2500 Participants Needed

Optical Sensor Detection for Oral Diseases

Recruiting at 1 trial location
HK
HK
NW
Overseen ByNicole Wakida, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

The optical sensor detection methods for oral diseases are generally considered safe as they are non-invasive, do not use harmful radiation, and are designed to be patient-friendly.12345

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?

PW

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

I may or may not have a lesion in my mouth.
I have gum disease.
You do not smoke cigarettes.
See 1 more

Exclusion Criteria

I am under 18 years old.
Immune compromised individuals
Pregnant or breastfeeding
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

up to 12 months

Follow-up

Participants are monitored for safety and effectiveness of the imaging modalities and data correlation with oral pathology stages.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Detection of Oral Pathology
Trial Overview The study aims to develop a new non-invasive method using light-based technologies to detect and diagnose oral diseases. Techniques include Coherence Tomography, Laser Speckle Imaging, Spectroscopy and Fluorescence compared against traditional clinical evaluations.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Oral tissueExperimental Treatment1 Intervention
Imaging of oral structures and pathologies

Detection of Oral Pathology is already approved in China, United States, European Union for the following indications:

🇨🇳
Approved in China as Photodynamic Diagnosis for:
  • Oral leukoplakia
  • Oral squamous cell carcinoma
🇺🇸
Approved in United States as Photodynamic Therapy for:
  • Actinic keratosis
  • Barrett's esophagus
  • Basal cell carcinoma
🇪🇺
Approved in European Union as Photodynamic Diagnosis for:
  • 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

Trials
580
Recruited
4,943,000+

Livionex Inc.

Industry Sponsor

Trials
4
Recruited
2,800+

Beckman Laser Institute University of California Irvine

Collaborator

Trials
78
Recruited
5,000+

Orahealth

Collaborator

Trials
1
Recruited
2,500+

Livionex Inc

Collaborator

Trials
3
Recruited
2,700+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials
102
Recruited
21,600+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials
312
Recruited
853,000+

Published Research Related to This Trial

A portable spectroscopy device was tested on 79 oral sites from 33 subjects, including 28 patients with oral lesions, showing high accuracy in identifying oral cancer with an area under the curve (AUC) of 0.90 for nonkeratinized sites.
The device also demonstrated good efficacy for keratinized sites, with an AUC of 0.83, indicating its potential as a noninvasive tool for early oral cancer diagnosis.
Prospective evaluation of a portable depth-sensitive optical spectroscopy device to identify oral neoplasia.Schwarz, RA., Gao, W., Stepanek, VM., et al.[2021]
Emerging optical diagnostic tools for the oral cavity offer non-invasive, radiation-free, and patient-friendly options for detecting and diagnosing early diseases, which is crucial as the focus shifts towards disease prevention and reversal.
These technologies provide real-time, high-resolution imaging of both soft and hard tissues, making them valuable for diagnosing oral mucosal lesions and dental pathologies.
Optical diagnostics in the oral cavity: an overview.Wilder-Smith, P., Holtzman, J., Epstein, J., et al.[2021]
Fluorescence imaging using 5-aminolevulinic acid significantly improves the detection of premalignant and malignant lesions in the oral cavity, with a sensitivity of 83-90% and specificity of 79-89% based on a study of 71 patients.
This technique offers advantages over traditional methods, providing real-time diagnosis and in situ monitoring, making it a more patient-friendly option compared to surgical biopsies.
Fluorescence spectroscopy combined with 5-aminolevulinic acid-induced protoporphyrin IX fluorescence in detecting oral premalignancy.Sharwani, A., Jerjes, W., Salih, V., et al.[2016]

Citations

Prospective evaluation of a portable depth-sensitive optical spectroscopy device to identify oral neoplasia. [2021]
Optical diagnostics in the oral cavity: an overview. [2021]
Fluorescence spectroscopy combined with 5-aminolevulinic acid-induced protoporphyrin IX fluorescence in detecting oral premalignancy. [2016]
Noninvasive diagnosis of oral neoplasia based on fluorescence spectroscopy and native tissue autofluorescence. [2019]
Has fluorescence spectroscopy come of age? A case series of oral precancers and cancers using white light, fluorescent light at 405 nm, and reflected light at 545 nm using the Trimira Identafi 3000. [2020]
Non-Invasive Techniques for Detection and Diagnosis of Oral Potentially Malignant Disorders. [2017]
Clinical Evaluation of the Optical Filter for Autofluorescence Glasses for Oral Cancer Curing Light Exposed (GOCCLES®) in the Management of Potentially Premalignant Disorders: A Retrospective Study. [2022]
Optical diagnostic systems for assessing head and neck lesions. [2017]
Noninvasive evaluation of oral lesions using depth-sensitive optical spectroscopy. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Recent advances in optical diagnosis of oral cancers: Review and future perspectives. [2018]
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