跳至主要内容
临床试验/NCT02931032
NCT02931032Unknown不适用

Diagnosis of Common Oral Diseases by Signature Volatile Profiles

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Volatile Molecular Concentration of the Headspace Samples

研究概览

简要总结

Oral diseases tend to be exacerbated due to delayed diagnosis. Patients avoid visiting their dentist even for regular checkups, and develop late stage disease, jeopardizing the treatment outcome. There is an urgent need for an inexpensive and minimally invasive technology that would serve as a diagnostic aid, allowing 1) efficient early detection and 2) treatment customization. Diagnostic modalities based on the detection of volatile organic compounds in the exhaled air may answer this need.

The proposed research aims at investigating signature molecular patterns of common oral diseases, as a first step toward the development of a computerized non-invasive diagnostic breath test, based on the "Na-Nose" device.

The proposed research will be divided to three distinct stages. Stages 1-2 will serve for the detection and analysis of Volatile Organic Compounds connected with common oral diseases, and for the characterization of a specified diagnostic nano-receptor array. Stage 3 will serve for the clinical testing of the array and as a proof of concept.

In a pilot experiment, headspaces above colonies of S.mutans, S.sanguis, P.gingivalis and F.nucleatum were trapped and analyzed using Gas Chromatography Mass Spectrometry (GC-MS). A unique VOC signature, consisting of 20-35 molecules, was detected for each of the bacterial strains.

These promising results allow the development of an algorithm for statistical detection of oral diseases by their VOC profile alone. Bacteria and distressed tissues emit unique VOCs, and additional research is required with other types and strains of bacteria - including cultivation of samples from active periodontal and carious lesions.

The results of the proposed research may be revolutionary. A simple and non-invasive air sampling at home or in a drugstore will significantly increase patient compliance and curability rates, and decrease healthcare expenditure.

详细描述

Physicians in ancient Greece understood that smelling the breath of their patients can assist in diagnosis. However, while this rather primitive diagnostic method hasn't changed much over the centuries, there has been an increasing interest in recent years in improving methods of noninvasive early diagnosis for numerous metabolic and infectious diseases.

Currently, many diseases are missed and exacerbated because of delayed diagnosis. In dental medicine, patients tend to avoid visiting their dentist even for regular checkups, and thus they only appear at the clinic at a later, advanced stage of the disease, suffering of pain and discomfort that could have easily been prevented, and presenting late stage disease, thus jeopardizing the treatment outcome.

For these reason, there is an urgent need for an inexpensive and minimally invasive technology that would serve as a diagnostic aid, allowing 1) efficient early detection and 2) treatment customization.

Diagnostic modalities based on the detection of volatile organic compounds (henceforth VOCs), i.e. organic compounds with relatively high vapor pressure at room temperature, may be the answer for the aforementioned need.

"Electronic Noses" for the Detection of Volatile Organic Compounds in the Exhaled Air Disease-specific volatile organic compounds are produced mainly through changes in specific biochemical pathways in the body. Following their production by either human or bacterial cells, VOCs may be found in body fluids, including infected cells and/or their microenvironment, blood, breath, and saliva, among others. Thus, VOCs released from their origin can be directly detected from blood and the headspace of cells.

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

入排标准

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

入选标准

  • Healthy with a documented medical history
  • Suffer from active periodontal disease or dental caries

排除标准

  • Consumed alcohol in the past 24 hours
  • Unclear medical or dental history
  • Documented history of malignancy
  • Cardiovascular diseases, inflammatory bowel disease, diabetes, asthma, CF, tuberculosis, Parkinson's disease, Alzheimer's disease, rheumatic and autoimmune diseases, kidney diseases, COPD
  • Infectious respiratory conditions

结局指标

主要结局

Volatile Molecular Concentration of the Headspace Samples

时间窗: 48 hours

The headspace air above the culsample will be analyzed in GC-MS, resulting in a report of its molecular composition. Unique volatile organic compounds emitted by the bacteria may be found in the samples, serving as means to recognize the bacteria emitting them.

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

Yael Huri Hadad

Head, Department of Prosthodontics, Faculty of Dental Medicine

Hadassah Medical Organization

研究点 (2)

Loading locations...

相似试验