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临床试验/NCT00540774
NCT00540774已完成不适用

Optical Sensor for Photodynamic Detection of Oral Pathology

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 1,004 人开始时间: 2003年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,004
试验地点
2
主要终点
Healthy oral tissue

研究概览

简要总结

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

详细描述

Purpose of the research is to identify optical predictors and biomarkers of health and disease.

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

No masking other than an anonymization of data.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Oral tissue

Other

Imaging of oral structures and pathologies

干预措施: detection of oral pathology (Device)

结局指标

主要结局

Healthy oral tissue

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Petra E. Wilder-Smith

Professor of Surgery and Director of Dentistry

University of California, Irvine

研究点 (2)

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