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| ID | Type | Description | Link |
|---|---|---|---|
| R44CA265514 | U.S. NIH Grant/Contract | View source | |
| T31IR1825 | Other Grant/Funding Number | California Tobacco-Related Diseases Research Program | |
| R03EB014852 | U.S. NIH Grant/Contract | View source | |
| R01DE022831 | U.S. NIH Grant/Contract | View source | |
| LDG | Other Identifier | Livionex | |
| OE | Other Identifier | Oral Essentials | |
| UCI-08-52 | Other Identifier | UCI Chao Family Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
| Livionex Inc. | INDUSTRY |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral tissue | Other | Imaging of oral structures and pathologies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| detection of oral pathology | Device | detection of oral pathology |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petra Wilder-Smith, DDS, PhD | University of Calfornia Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beckman Laser Institute and Medical Clinic | Irvine | California | 92612 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2026 | Mar 18, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2026 | Mar 23, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009062 | Mouth Neoplasms |
| D013280 | Stomatitis |
| D010518 | Periodontitis |
| D014987 | Xerostomia |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Orahealth |
| UNKNOWN |
| National Cancer Institute (NCI) | NIH |
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No masking other than an anonymization of data.
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| D010510 |
| Periodontal Diseases |
| D012466 | Salivary Gland Diseases |
| D007239 | Infections |
| D005882 | Gingival Diseases |