Optical Sensor Detection for Oral Diseases

Recruiting at 1 trial location

Overseen By Nicole Wakida, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Disqualifiers: Advanced gum disease, untreated cavities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

2500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the detection and diagnosis of oral diseases using light-based imaging techniques, specifically through an optical sensor for detecting oral pathology. Researchers will compare these new methods to traditional diagnostic approaches to gain a better understanding of oral diseases and develop non-invasive detection methods. Participants may include individuals with oral issues such as gum disease, dry mouth, or oral sores, as well as those without any oral conditions. Non-smokers who are 18 or older and do not have advanced gum disease are well-suited for this study. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research in non-invasive oral disease detection.

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.

What prior data suggests that these optical imaging techniques are safe for detecting oral diseases?

Research has shown that light-based methods for detecting oral diseases are generally safe. Studies have found that non-invasive imaging techniques, like those used in this trial, are easy for patients to handle. For example, methods such as laser imaging and various light analyses have been used without causing harm or discomfort.

Previous research using similar optical tools has reported no safety issues. Since this trial does not test a new drug but uses imaging to examine oral health, the risks remain very low. Participants can feel confident about the safety of this approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Optical Sensor Detection for Oral Diseases because it offers a groundbreaking way to spot oral pathologies early. Unlike traditional methods like visual exams or biopsies, this approach uses advanced imaging technology to scan oral tissues for abnormalities quickly and non-invasively. This innovation could lead to earlier detection and diagnosis, which is crucial for effective treatment and better patient outcomes. By providing a more accurate and less intrusive diagnostic tool, this technology has the potential to revolutionize how we approach oral health.

What evidence suggests that this optical sensor is effective for detecting oral diseases?

This trial will evaluate the use of optical sensors for detecting oral diseases. Studies have shown that light and special sensors can effectively find and diagnose oral diseases. Research indicates these methods can highlight differences in mouth tissues, making it easier to spot issues like plaque, gum disease, and oral cancer. For example, certain techniques provide detailed pictures of the mouth's structures, while others reveal changes in blood flow and tissue health. These advanced techniques aim to offer a non-invasive way to identify oral problems early, potentially leading to better treatment outcomes. ^{1 2 3 4 5}

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

I may or may not have a lesion in my mouth.

I have gum disease.

You do not smoke cigarettes.

Exclusion Criteria

I am under 18 years old.

Immune compromised individuals

Pregnant or breastfeeding

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?

Group I: Oral tissue Experimental Treatment 1 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

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

Novel optical-based diagnostic systems can enhance clinical assessments by providing rapid, real-time diagnosis of oral and head and neck lesions, serving as an adjunct to traditional histopathological methods.

These systems utilize different wavelengths of light to detect tissue changes, which can lead to quicker and more accurate identification of lesions, improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical diagnostic systems for assessing head and neck lesions. Green, B., Tsiroyannis, C., Brennan, PA.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical diagnostics in the oral cavity: an overview. Wilder-Smith, P., Holtzman, J., Epstein, J., et al.[2021]

Fluorescence spectroscopy can effectively differentiate between normal and abnormal oral mucosa, showing significant differences in spectral characteristics between healthy tissue and lesions, with a sensitivity of 88% and specificity of 100% for one diagnostic algorithm.

This noninvasive technique has the potential to enhance the early detection of oral cavity neoplasia, which could lead to better outcomes in managing premalignant and malignant lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive diagnosis of oral neoplasia based on fluorescence spectroscopy and native tissue autofluorescence. Gillenwater, A., Jacob, R., Ganeshappa, R., et al.[2019]

A prototype optical spectroscopy device using multiple light wavelengths (white, green-amber at 545 nm, and violet at 405 nm) has shown promise in enhancing the detection of oral precancerous lesions compared to standard white light examination in a study involving over 300 patients across two clinical sites.

The device's use of violet light-induced fluorescence and green-amber reflectance improved visualization of lesion characteristics, such as abnormal vasculature and stromal changes, suggesting it could significantly increase the sensitivity of oral cancer screenings when used by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lane, P., Follen, M., MacAulay, C.[2020]

Early detection of oral potentially malignant disorders (PMDs) is crucial for preventing the progression to oral squamous cell carcinoma (OSCC), which remains a significant health concern due to high morbidity and mortality rates.

The review evaluates various non-invasive diagnostic techniques, such as vital staining, light-based detection systems, optical technologies, and salivary biomarkers, highlighting their potential effectiveness in screening and monitoring PMDs, along with their sensitivity and specificity for detecting these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Invasive Techniques for Detection and Diagnosis of Oral Potentially Malignant Disorders. Liu, D., Zhao, X., Zeng, X., et al.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescence spectroscopy combined with 5-aminolevulinic acid-induced protoporphyrin IX fluorescence in detecting oral premalignancy. Sharwani, A., Jerjes, W., Salih, V., et al.[2016]

Optical diagnosis techniques for oral cancer, such as fluorescence and Raman spectroscopy, offer advantages like objectivity, speed, and cost-effectiveness, potentially transforming cancer management workflows.

Recent in vivo human clinical studies are exploring the clinical application of these noninvasive methods, highlighting their promise as adjunct tools to traditional diagnostic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in optical diagnosis of oral cancers: Review and future perspectives. Singh, SP., Ibrahim, O., Byrne, HJ., et al.[2018]

The depth-sensitive optical spectroscopy (DSOS) system demonstrated high diagnostic performance in distinguishing dysplastic and cancerous oral lesions from non-neoplastic tissue, achieving a sensitivity and specificity comparable to expert clinical diagnosis.

In a study involving 124 subjects and 424 oral sites, the DSOS system's algorithms showed an impressive area under the curve of 0.96 in training and 0.93 in validation, indicating its potential as a reliable tool for early oral cancer detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive evaluation of oral lesions using depth-sensitive optical spectroscopy. Schwarz, RA., Gao, W., Redden Weber, C., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of a portable depth-sensitive optical spectroscopy device to identify oral neoplasia. Schwarz, RA., Gao, W., Stepanek, VM., et al.[2021]

In a study of 25 patients with oral potentially malignant disorders (OPMDs), toluidine blue staining demonstrated higher sensitivity (91%) and accuracy (75%) compared to the autofluorescence evaluation with GOCCLES®, which had a sensitivity of 66% and accuracy of 53%.

Both diagnostic methods, while effective in identifying dysplastic areas, cannot reliably differentiate between benign and malignant lesions, highlighting the need for further histopathological analysis after initial screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Lajolo, C., Tranfa, M., Patini, R., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT00540774/optical-sensor-for-photodynamic-detection-of-oral-pathology

Optical Sensor for Photodynamic Detection of Oral Pathology Overall objective of this work is to develop better ways of detecting, diagnosing and measuring oral diseases and structures using light and ...

2. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT00540774

Optical Sensor for Photodynamic Detection of Oral Pathology Overall objective of this work is to develop better ways of detecting, diagnosing and measuring oral diseases and structures using light and ...

3. clinconnect.io clinconnect.io/trials/NCT00540774

Optical Sensor for Photodynamic Detection of Oral - ClinConnect This clinical trial is focused on finding better ways to detect and diagnose various mouth diseases using light and special imaging techniques.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0968089624003766

Photodynamic therapy: An emerging therapeutic modality ... Photodynamic Therapy (PDT) is a rapidly evolving, non-invasive treatment modality with considerable promise in dental pharmacotherapeutics.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5996863/

Intraoperative optical assessment of photodynamic therapy ... This study investigated whether diffuse optical spectroscopy (DOS) measurements could assess clinical response to photodynamic therapy (PDT) in patients ...