None listed
Conditions
Brief summary
This study aims to assess whether non-invasive methods (imaging and mouth swabs) can detect early signs of oral cancer in people with changes in the soft tissues of their mouth. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with an oral soft tissue disease, this may include oral cancer, periodontitis (gum disease), pre-cancerous tissue changes and other oral lesions; and you are undergoing treatment with a doctor or dentist for your condition. Study details All participants who choose to enrol in this study will be asked to attend an appointment at your usual treatment location . During the appointment, the dentist will use two types of camera to take regular and heat-sensitive images of the inside and outside of your mouth and will ask you to provide a saliva sample and cheek/tongue swabs for assessment. The appointment should take no more than 20 minutes. Individual image captures will not be provided to participants. Your care will continue as usual. It is hoped this research will determine whether these non-invasive methods can help doctors and dentists spot oral cancer earlier, which may reduce the need for unnecessary surgeries, and ideally would make the process easier and less stressful for patients. signs of oral cancer in people with changes in the soft tissues of their mouth. Instead of relying only on traditional biopsies, the study will test new tools—such as special cameras that take regular and heat-sensitive photos, and simple mouth rinse or gentle brush samples—to see if they can accurately identify which mouth changes are at risk of becoming cancer. The main idea is that these new, non-invasive methods can help doctors and dentists spot cancer earlier, reduce the need for unnecessary surgeries, and make the process easier and less stressful for patients. The study's hypothesis is that these non-invasive tools will be just as good, or better, than current methods at telling the difference between harmless and risky mouth changes, leading to earlier and more accurate treatment for those who need it.
Interventions
This observational clinical trial is a cross-sectional study designed to evaluate non-invasive diagnostic tools for early detection of oral cancer in adults with oral mucosal diseases.
Condition Observed
• Target Population: Adults (equal or greater than 18 years) with oral soft tissue diseases, including gingivitis, periodontitis, leukoplakia without dysplasia, oral dysplasia, oral lichenoid lesions, oral lichen planus, or other oral mucosal disorders.
• Clinical Focus: The study observes both
This observational clinical trial is a cross-sectional study designed to evaluate non-invasive diagnostic tools for early detection of oral cancer in adults with oral mucosal diseases. Condition Observed • Target Population: Adults (equal or greater than 18 years) with oral soft tissue diseases, including gingivitis, periodontitis, leukoplakia without dysplasia, oral dysplasia, oral lichenoid lesions, oral lichen planus, or other oral mucosal disorders. • Clinical Focus: The study observes both cancerous and non-cancerous oral mucosal changes, aiming to distinguish between them using non-invasive methods. The exposures will be administered by AHPRA registered oral health professional researcher. These procedures are accessed because of enrollment in the study and will otherwise not form part of the patients clinical assessment. Exposure Details • Non-Invasive Tools Used: 1. Single-lens Reflex (SLR) Photography: Imaging of lips, buccal mucosae, gingivae, tongue, and palate. 2. Thermal Imaging (ThermOralCam): Captures thermal flux data from intraoral sites to detect abnormal heat signatures associated with cancerous tissue. 3. Oral Swirl: Participants rinse with sterile water for 50 seconds and provide the sample for molecular analysis (microRNA-based risk assessment). 4. Brush Sample: A soft brush collects cells from the lesion surface. 5. Oral Scrape: A dermatological curette collects surface cells from lesions. • Investigational Product: The study does not administer any drugs or experimental treatments; all exposures are non-invasive sample collections and imaging. The investigational product is the thermal-camera. The total participation time is up to 20 minutes per patient SLR photograph (5 minutes) and Thermal imaging (10 minutes) may total 15 minutes and the collection of the oral swirl, brush and scrape may take up to 5 minutes. The results of these tests will not impact subsequent treatment or clinical recommendations made to participants. The collection will take in a consulting room or dental surgery room. Diagnosis will be determined as per standard care and the results from the administered investigational tools (exposure) will be not be available to participants. Duration of Observation • Study Timeline: The protocol is planned for 3 years (2026–2029). • Participant Involvement: Each participant is assessed at a single time point coinciding with their scheduled clinical visit for oral disease management. No further follow-up is required from participants after sample and data collection. • Recruitment Goal: Up to 150 participants will be enrolled over the 3-year period.
Sponsors
University of Melbourne
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Individuals with oral soft tissue diseases (e.g., oral cancer gingivitis, periodontitis, leukoplakia without dysplasia, oral dysplasia, oral lichenoid lesions, oral lichen planus, or other oral mucosal disorders) Age 18 years or older Presenting for standard oral care including pre-surgery Able to provide informed consent
Exclusion criteria
None
Outcome results
None listed