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Optical Sensor for Photodynamic Detection of Oral Pathology

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
Otolaryngology Medical Clinic,University of California, Irvine
Colgate Palmolive
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00540774
First received: October 4, 2007
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

The researcher can identify the changes in the optical properties of oral tissues, and can compare these with conventional semi-quantitative histo-pathological assessment to (1) determine 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:
  • Optical Sensor for Photodynamic Detection of Oral Pathology [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

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:

Researchers of the Beckman Laser Institute have developed non-invasive imaging modalities for assessment of oral tissue.

The Imaging modalities include:

  1. Coherence and Doppler Tomography a non-invasive imaging modality serves as an alternative to invasive tissue biopsy as a diagnostic measure. Non-invasive diagnosis, which is easier to implement and more convenient than tissue biopsy, can also reduce procedural complications.
  2. Laser Speckle Imaging can image the microstructure and blood flow of the oral tissue. This system is valuable in the treatment and diagnosis of both benign and malignant diseases in the oral cavity.
  3. Photon Migration Spectroscopy is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues. The PMS measurements can provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.
  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

Locations
United States, California
Beckman Laser Institute, University of California Irvine
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Otolaryngology Medical Clinic,University of California, Irvine
Colgate Palmolive
Investigators
Principal Investigator: Petra Wilder-Smith, DDS,PhD Beckman Laser Institute, University of Calfornia Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540774     History of Changes
Other Study ID Numbers: NIH/LAMMP-2002-2805
Study First Received: October 4, 2007
Last Updated: October 28, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 20, 2014