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Trial record 17 of 48 for:    gum disease AND oral | ( Map: United States ) | NIH

Optical Sensor for Photodynamic Detection of Oral Pathology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00540774
Recruitment Status : Withdrawn (Not a clinical trial study.)
First Posted : October 8, 2007
Last Update Posted : January 25, 2018
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Essentialis, Inc.
Orahealth
National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine

Tracking Information
First Submitted Date October 4, 2007
First Posted Date October 8, 2007
Last Update Posted Date January 25, 2018
Study Start Date April 2003
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2014)
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
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00540774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Optical Sensor for Photodynamic Detection of Oral Pathology
Official Title Optical Sensor for Photodynamic Detection of Oral Pathology
Brief Summary

Overall objective of this work is to identify optical properties of healthy, diseased, dysplastic and malignant oral tissues, to compare these with conventional diagnostic approaches such as standard of care clinical techniques as well as semi-quantitative histo-pathological assessment and potential biomarkers in oral tissues and fluids 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. 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. Coherence and Doppler Tomography
  2. Laser Speckle Imaging
  3. Various forms of Spectroscopy
  4. Fluorescence
Detailed Description

Purpose of the research is to identify optical predictors and biomarkers of oral pathology 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:

  1. Coherence and Doppler Tomography (OCT)
  2. Laser Speckle Imaging (LSI)
  3. Photon Migration Spectroscopy (PMS)
  4. 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study population will be recruited from University of Californis Irvine and Orange Country Dentists.
Condition Mouth Diseases
Intervention Device: detection of oral pathology
detection of oral pathology
Study Groups/Cohorts Oral tissue
detection of oral pathology
Intervention: Device: detection of oral pathology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 23, 2018)
0
Original Estimated Enrollment
 (submitted: October 4, 2007)
84
Estimated Study Completion Date July 2018
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age less than 18 years old
  • Advanced gum disease, diseases of oral tissue
  • Untreated cavities
  • Pregnant or breastfeeding
  • Immune compromised individuals
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00540774
Other Study ID Numbers NIH/LAMMP-2002-2805
CRO-2009-XER-01-DM ( Other Identifier: COLGATEPALMOLIVE )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Beckman Laser Institute and Medical Center, University of California, Irvine
Study Sponsor University of California, Irvine
Collaborators
  • Beckman Laser Institute University of California Irvine
  • Essentialis, Inc.
  • Orahealth
  • National Institutes of Health (NIH)
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Petra Wilder-Smith, DDS,PhD Beckman Laser Institute, University of Calfornia Irvine
PRS Account University of California, Irvine
Verification Date January 2018