Mouth DiseasesNCT00540774
Optical Sensor for Photodynamic Detection of Oral Pathology
A study testing detection of oral pathology in people with Mouth Diseases, run by University of California, Irvine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mouth Diseases
- What is being tested?
- detection of oral pathology
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,004 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to 3 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female age 18 years and older
- Have oral lesion or not have oral lesion
- Have condition of dry mouth
- Have condition of Gum disease
- Non-smoker
Who cannot join
- Age less than 18 years old
- Advanced gum disease, diseases of oral tissue
- Untreated cavities
- Pregnant or breastfeeding
- Immune compromised individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute and Medical Clinic
Irvine, California, 92612
About this study
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
- Fluorescence
Read the detailed description
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.
- Conditions
- Mouth Diseases
- Being tested
- detection of oral pathology
- Keywords
- Oral cancer, Oral mucositis, Periodontitis, Dry mouth, Gingivitis, Oral lesions, Dental Hard Tissues, Oral Biofilm
- Medical subject headings
- Mouth Diseases, Mouth Neoplasms, Stomatitis, Periodontitis, Xerostomia, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detection of oral pathologyDevice
detection of oral pathology
| Study group | Role | What they receive |
|---|---|---|
| Oral tissue | Other | Imaging of oral structures and pathologies Receives: Device: detection of oral pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy oral tissue
Develop a non-invasive tool for the detection, diagnosis and screening of oral pathology and understanding of processes involved in oral pathology
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startApr 2003
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mouth DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute of Dental and Craniofacial Research (NIDCR), Livionex Inc., Orahealth, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Petra E. Wilder-Smith, University of California, Irvine
- Investigators
- Petra Wilder-Smith, DDS, PhD, Principal investigator, University of Calfornia Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540774
- Sponsor's protocol ID
- 20022805
- Other IDs
- R44CA265514, T31IR1825, R03EB014852, R01DE022831, LDG, OE, UCI-08-52
- Status last verified
- Apr 2026
- First submitted
- 4 Oct 2007
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Sensor for Photodynamic Detection of Oral Pathology
- ClinicalTrials.gov ID
- NCT00540774
- Acronym / sponsor ID
- 20022805
- Conditions
- Mouth Diseases
- Keywords
- Oral cancer, Oral mucositis, Periodontitis, Dry mouth, Gingivitis, Oral lesions, Dental Hard Tissues, Oral Biofilm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institute of Dental and Craniofacial Research (NIDCR), Livionex Inc., Orahealth, National Cancer Institute (NCI)
- Study start
- Apr 2003
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 8 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Fluorescence
Detailed description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral tissue | Other | Device: detection of oral pathologyImaging of oral structures and pathologies |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female age 18 years and older
- Have oral lesion or not have oral lesion
- Have condition of dry mouth
- Have condition of Gum disease
- Non-smoker
Key exclusion criteria (5 listed)
- Age less than 18 years old
- Advanced gum disease, diseases of oral tissue
- Untreated cavities
- Pregnant or breastfeeding
- Immune compromised individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| detection of oral pathologydetection of oral pathology | Device | Oral tissue |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petra Wilder-Smith, DDS, PhD principal investigator
University of Calfornia Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing detection of oral pathology in people with Mouth Diseases, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy oral tissue (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.