Diagnosis of Common Oral Diseases by Signature Volatile Profiles
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Volatile Molecular Concentration of the Headspace Samples
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy with a documented medical history
- •Suffer from active periodontal disease or dental caries
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Volatile Molecular Concentration of the Headspace Samples
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Yael Huri Hadad
Head, Department of Prosthodontics, Faculty of Dental Medicine
Hadassah Medical Organization