NCT00540774

Brief 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 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:

  1. 1.Coherence and Doppler Tomography
  2. 2.Laser Speckle Imaging
  3. 3.Various forms of Spectroscopy
  4. 4.Fluorescence

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,004

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2007

Completed
18.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

22.9 years

First QC Date

October 4, 2007

Last Update Submit

April 4, 2026

Conditions

Mouth Diseases

Keywords

Oral cancerOral mucositisPeriodontitisDry mouthGingivitisOral lesionsDental Hard TissuesOral Biofilm

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Oral tissue

OTHER

Imaging of oral structures and pathologies

Device: detection of oral pathology

Interventions

detection of oral pathologyDEVICE

detection of oral pathology

Oral tissue

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age less than 18 years old
  • Advanced gum disease, diseases of oral tissue
  • Untreated cavities
  • Pregnant or breastfeeding
  • Immune compromised individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute and Medical Clinic

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Mouth DiseasesMouth NeoplasmsStomatitisPeriodontitisXerostomiaGingivitis

Condition Hierarchy (Ancestors)

Stomatognathic DiseasesHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsPeriodontal DiseasesSalivary Gland DiseasesInfectionsGingival Diseases

Study Officials

  • Petra Wilder-Smith, DDS, PhD

    University of Calfornia Irvine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking other than an anonymization of data.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery and Director of Dentistry

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 8, 2007

Study Start

April 1, 2003

Primary Completion

March 3, 2026

Study Completion

March 3, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

US(1)