Optical Sensor for Photodynamic Detection of Oral Pathology
Phase: NA
Conditions: Mouth Diseases
Sponsor: University of California, Irvine

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20022805
Basic Study Information
Date: Tuesday, March 10, 2026 12:12:07 PM
 
1.  Title of study:
Optical Sensor for Photodynamic Detection of Oral Pathology
2.  Short title:
Optical Sensor for Photodynamic Detection of Oral Pathology
3.  Brief description:
Overall objective of this work is to identify changes in the optical properties of healthy,
dysplastic and malignant tissues, to compare these with conventional semi-quantitative
histo-pathological assessment and to correlate these findings with potential salivary
biomarkers 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.
Specific aims of this study are:
1. To map the auto-fluorescence, absorption and reflection spectra and images of healthy
and pathological oral tissues and to correlate these with oral pathology. Rationale is that
tissue architecture, components, metabolic processes and vasculature change with the
onset and progression of pathology. Each of these factors has optical signatures that can
be detected non-invasively. Additionally, each of these processes has a unique molecular
signature which includes identifiable characteristics of activities of genes, proteins or
other molecules resulting in dysregulation of cell proliferation and inherent death
mechanisms.
2. To determine process-based downregulation/upregulation of specific molecules as
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biomarkers or predictors of oral neoplasia and pathology by means of crevicular fluid and
salivary analyses and
3. To correlate investigate the correlation between these findings to enable a better
understanding for the prediction of current and future behavior of oral premalignant and
malignant and other gingival and periodontal conditions.
4. Identify salivary transcriptomes that are involved in dysregulation of cell proliferation
and inherent death mechanisms using quantitative polymerase chain reaction and
microarray-based gene profiling in patients with leukoplakia and erythroplakia
5. Evaluate the downregulation/upregulation of determined transcriptomes at different
stages of oral dysplasia,
6. Identify potential salivary biomarkers of gingivitis, periodontitis, dysplasia and
progression that will provide the basis for future extensive studies.
4.  What kind of study is this?
Single-site study
5.  Will an external IRB act as the IRB of record for this study?
  Yes No 
6.  Local (UCI) principal investigator (PI):
Petra Wilder-Smith
7.  Does the Local PI or their immediate family have a financial interest
related to this research?
  Yes No
8. 
 Attach the Human Subject Protocol Supplement:
 
Document
Category Date
Modified
Document
History
View

20022805_PDF.pdf(0.01)
IRB
Protocol
9/6/2025 History
9. PI Eligibility: Yes 
10. PI Position/Title:
RECALL HCOMP 
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11.  PI Affiliation:
UCI Faculty 
12.  Is the PI a United States (US) licensed medical doctor or US
licensed nurse practitioner?  
Yes
No
13.  PI Earned / Honorary Degree:
Other 
14.  List the research activities/procedures to be performed by the PI
and the individual’s relevant qualifications (training/experience):
Duties: Oversight of Research
Petra Wilder-Smith, DDS, PhD, is a Professor and Director of Dentistry at Beckman
Laser Institute. She has been UCI faculty for over 20 years, and has worked on a wide-
range of related, grant and foundation-sponsored projects. She will be recruiting,
consenting and perform the OCT, autofluorescence imaging and LSI imaging until
standardize techniques have been established. Then she will train her researchers to
perform imaging. She will perform an oral exam and identify the study site. She will have
access to subject PHI. At Concorde College of Dental Hygiene (CCDH) and West Coast
University (WCU) Dental Hygiene Clinic as a part of the saliva study, Dr. Wilder-Smith will
be responsible for subject recruitment, obtaining informed consent, saliva collection, and
she will have access to subjects’ PHI and medical records. 
15.  Lead unit (i.e. Department, Organized Lead Unit, Center or Institute):
BECKMAN LASER INST & MED CLNC
16.  Local (UCI) principal Investigator (PI) Primary
School/Department/Program:
Biomedical (Health Sciences)
17.  Submission Type:
Expedited Research 
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20022805
Study Funding Sources
1. Identify each organization supplying funding for the study:
Funding Source
Sponsor's
Funding ID Grants Office ID Attachments
Department Funded
 
 
 
MISCELLANEOUS
SPONSORS
 
T31IR1825
(UCI
KR#2471992)
 
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20022805
Local Study Team Members
1. Identify each additional person involved in the design, conduct, or
reporting of the research:
Name
Roles
Financial
Interest
Involved
in
Consent
E-mail
Phone
Thair
Takesh
Research
Assistant no
no
ttakesh@uci.edu
 
Nicole
Wakida
Research
Assistant no
no
nwakida@hs.uci.edu  
2. External Study Team Members for UCI:
Name
Description
There are no items to display
3.  Are research personnel (RP) tracked outside the approved protocol,
in accordance with the Research Team Table?
  Yes No 
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20022805
Study Scope
1.  Does the study specify the use of an approved drug or biologic, use
an unapproved drug or biologic, or use a food or dietary supplement
to diagnose, cure, treat, or mitigate a disease or condition?
  Yes No
2.  Does the study require the use of a device?
  Yes No
3.  Does this research meet the definition of a clinical trial that requires
adherence to Clinicaltrials.gov (CT.gov)?
  Yes No 
4.  Provide the CT.gov registration number:
NCT00540774 
5.  Specify who initiated / authored the project:
Investigator
6.  Is this project cancer related?
  Yes No 
 
1.  Research Procedures (select all that apply):
Collection of Other Samples/Biospecimens (e.g., tissue, saliva, urine)
Genetic Analysis
Non-invasive Physical Measurements (e.g., ECG, EEG, moderate exercise, muscular
strength testing, body composition assessment)
Research Requires Use of Device
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Research Requires Use of Drug or Biological Product (including the on or off label use
of an FDA approved drug)
Secondary use of Identifiable Private Information (i.e., Medical/Student Records)
Use of Placebo, Placebo Washout or Sham Procedure
2.  Specify if any of the following materials are used for research-
related purposes (select all that apply):
Not Applicable
3.  Will this study use any UCI Health space and/or require clinical
services from UCI Health? (This includes space, items, or services at
all UCI owned sites, including campus.)
  Yes No 
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20022805
Local Research Locations
1. Identify research locations where research activities will be
conducted or overseen by the local investigator:
 Location
Contact
Phone
Email
There are no items to display
2.  Are research subjects and/or performance sites located outside the
United States (i.e. international research)?
  Yes No 
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20022805
Drugs
1.  List all drugs, biologics, foods, and dietary supplements to be used
in the study: 
 
Generic/brand
name
Investigational
drug name
Drug
type
Attachment
name
Comments
View
Colgate product
with
Trimethylglycine
(Betaine)
N/A
Drug  
 
View
Lumineux
Clean and
Fresh
Mouthwash
Lumineux
Clean and
Fresh
Mouthwash
Drug  
 
2.  Will the study be conducted under any IND numbers?
  Yes No
3. Attach files: (such as IND or other information that was not attached for a specific
drug) 
 Document
Category
Date Modified
Document History
There are no items to display
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20022805
Devices
1.  Select each device the study will use as an HUD or evaluate for
safety or effectiveness:
 
Device
Humanitarian
Use Device
Attachment
Name
FDA
Regulated
Device
Exemption
Apply?
Comments
View
Carestream
CS1600
no
 
 
 
 
2.  Device exemptions applicable to this study: Exempt from IDE
requirements
3. Attach files: (such as IDE, HDE, or other information that was not attached for a
specific device)
 Document
Category
Date Modified
Document History
There are no items to display
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20022805
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20022805
Local Site Documents
1. Consent forms: (include an HHS-approved sample consent document, or sponsor
template, if applicable)
 
Document
Category
Date
Modified
Document
History
View
20022805 Saliva
Study Consent 02-20-
25.pdf(0.01)
Consent
Form
9/6/2025
History
View
20022805 Saliva
Study Consent 02-20-
25.docx(0.01)
Consent
Form
9/6/2025
History
View
20022805 Pulpal
Vitality Study Consent
02-20-25.pdf(0.01)
Consent
Form
9/6/2025
History
View
20022805 Pulpal
Vitality Study Consent
02-20-25.docx(0.01)
Consent
Form
9/6/2025
History
View
20022805 Gum
Study Consent 02-20-
25.pdf(0.01)
Consent
Form
9/6/2025
History
View
20022805 Gum
Study Consent 02-20-
25.docx(0.01)
Consent
Form
9/6/2025
History
View
20022805 Dry
Mouth Study Consent
03-15-22 (CE 6-9-
16).docx(0.01)
Consent
Form
9/6/2025
History
View
20022805 Consent
Form 02-20-
25.docx(0.01)
Consent
Form
9/6/2025
History
View
20022805 Consent
Form + HIPAA Autho 02-
20-25.pdf(0.01)
Consent
Form
9/6/2025
History
2. Recruitment materials: (add all material to be seen or heard by subjects, including
ads)
 
Document
Category
Date
Modified
Document
History
View
2002-2805 Recruitment
Brochure for GUM Study 10-
22-
12_normal_166105.doc(0.01)
Recruitment
Material
9/6/2025 History
View
2002-2805 Recruitment
Brochure for GUM Study 10-
Recruitment
Material
9/6/2025 History
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20022805
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Document
Category
Date
Modified
Document
History
22-
12_approved_166105.pdf(0.01)
View
2002-2805 New GUM
Recruitment Flyer 11-16-
15_normal_253710.pdf(0.01)
Recruitment
Material
9/6/2025 History
View
2002-2805 New GUM
Recruitment Flyer 11-16-
15_approved_253710.pdf(0.01)
Recruitment
Material
9/6/2025 History
View
2002-2805 Crevicular Fluid
and Saliva Recruitment Flyer
08-01-
19_normal_365928.pdf(0.01)
Recruitment
Material
9/6/2025 History
View
2002-2805 Crevicular Fluid
and Saliva Recruitment Flyer
08-01-
19_approved_365928.pdf(0.01)
Recruitment
Material
9/6/2025 History
3. Other attachments:
 
Document
Category
Date
Modified
Document
History
View
Study_Calendar.png(0.01)
Other
9/6/2025 History
View
San Joaquin Valley College
Letter of Support.pdf(0.01)
Letter of
Permission or
Collaboration
9/6/2025 History
View
Pathology Waiver 02-12-
13_normal_175714.pdf(0.01)
Other
9/6/2025 History
View
Demographics
Survey.docx(0.01)
Other
9/6/2025 History
View
20022805 HIPAA Authorizaton
03-15-22.docx(0.01)
HIPAA
Research
Authorization
Form
9/6/2025 History
View
20022805 Amend & Renew
Approval Letter 02-20-25.pdf(0.01)
UCI IRB
Approval Letter 9/6/2025 History
View
2002-2805 WCU Letter of
Support
6.24.2021_normal_415322.pdf(0.01)
Letter of
Permission or
Collaboration
9/6/2025 History
View
2002-2805 Visual analogue
scales_normal_78458.doc(0.01)
Other
9/6/2025 History
View
2002-2805 Photography
Consent 4-11-
11_normal_94984.doc(0.01)
Other
9/6/2025 History
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Document
Category
Date
Modified
Document
History
View
2002-2805 Normal and Oral
Lesion DAS 10-22-
12_normal_166108.doc(0.01)
Data Collection
Tool/Instrument 9/6/2025 History
View
2002-2805 Normal and Oral
Lesion DAS 10-22-
12_approved_166108.pdf(0.01)
Data Collection
Tool/Instrument 9/6/2025 History
View
2002-2805 NIH Grant 04-08-
14_normal_207624.pdf(0.01)
Other
9/6/2025 History
View
2002-2805 ICTS CCRI
award_normal_274697.doc(0.01)
Other
9/6/2025 History
View
2002-2805 Gum Study DAS 10-
22-12_normal_166106.doc(0.01)
Data Collection
Tool/Instrument 9/6/2025 History
View
2002-2805 Gum Study DAS 10-
22-12_approved_166106.pdf(0.01)
Data Collection
Tool/Instrument 9/6/2025 History
View
2002-2805 Dry Mouth DAS 10-
22-12_normal_166107.doc(0.01)
Data Collection
Tool/Instrument 9/6/2025 History
View
2002-2805 Data Collection
Sheet- Dry
Mouth_normal_84718.doc(0.01)
Other
9/6/2025 History
View
2002-2805 Colgate company
letter_normal_77452.pdf(0.01)
Other
9/6/2025 History
View
2002-2805 Carestream
Brochure_normal_273485.pdf(0.01)
Medical Device
Instructions
(User
Manual/Product
Brochure)
9/6/2025 History
 Suggested attachments:
Completed checklist of meeting Department of Energy requirements, if applicable
Other site-related documents not attached on previous forms
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Add / Edit
1.  Funding organization:
Department Funded
2. Sponsor's funding ID: (assigned by external sponsor)
3. Grants office ID: (assigned internally)
4. Attach files: (include any grant applications)
 Document
Category
Date Modified
Document History
There are no items to display
5.  Is UCI the prime recipient of the award?
  Yes No 
 
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20022805
Add / Edit
1.  Funding organization:
MISCELLANEOUS SPONSORS
2. Sponsor's funding ID: (assigned by external sponsor)
3. Grants office ID: (assigned internally)
T31IR1825 (UCI KR#2471992)
4. Attach files: (include any grant applications)
 Document
Category
Date Modified
Document History
There are no items to display
5.  Is UCI the prime recipient of the award?
  Yes No 
 
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