Optical Sensor for Photodynamic Detection of Oral Pathology

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by University of California, Irvine
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540774
First received: October 4, 2007
Last updated: August 4, 2015
Last verified: August 2015
  Purpose

Overall objective of this work is to identify changes in the optical properties of tissues, and to compare these with conventional semi-quantitative histo-pathological assessment to (1) gain a better understanding of processes involved in oral pathology and (2) develop a non-invasive tool for the detection, diagnosis and screening of oral pathology.


Condition Intervention
Mouth Diseases
Device: detection of oral pathology

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Sensor for Photodynamic Detection of Oral Pathology

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Healthy oral tissue [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    Develop a non-invasive tool for the detection, diagnosis and screening of oral pathology and understanding of processes involved in oral pathology


Estimated Enrollment: 150
Study Start Date: April 2003
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Oral tissue
detection of oral pathology
Device: detection of oral pathology
detection of oral pathology

Detailed Description:

The researcher can use Optical Sensor for imaging the oral tissues. The Imaging system is a non-invasive imaging device and can measure the change in oral tissues. This imaging device is a non-invasive, non-significant risk use for optical tissue biopsy and can reduce procedural complication from clinical standard surgical tissue biopsy procedure.

The imaging devices are;

  1. Coherence and Doppler Tomography (OCT)
  2. Laser Speckle Imaging (LSI)
  3. Photon Migration Spectroscopy (PMS)

The researcher use toothpaste call Livionex Colgate Product to evaluate oral tissues changes and use the imaging devices to measure the changes of oral tissues.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study population will be recruited from University of Californis Irvine and Orange Country Dentists.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540774

Contacts
Contact: Montana Compton, R.N 949-824-9265 mocomton@uci.edu

Locations
United States, California
Beckman Laser Institute, University of California Irvine Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, R.N    949-824-9265    mocomton@uci.edu   
Principal Investigator: Petra Wilder-Smith, DDS,PhD         
Sub-Investigator: Montana Compton, RN         
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Petra Wilder-Smith, DDS,PhD Beckman Laser Institute, University of Calfornia Irvine
  More Information

No publications provided

Responsible Party: Beckman Laser Institute and Medical Center, Petra Wilder-Smith, DDS., PhD., Director of Dentistry, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540774     History of Changes
Other Study ID Numbers: NIH/LAMMP-2002-2805, CRO-2009-XER-01-DM
Study First Received: October 4, 2007
Last Updated: August 4, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
oral cancer
oral mucositis
oral stomatitis
Dry mouth
Gingivitis

Additional relevant MeSH terms:
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 27, 2015