Diagnosis of Common Oral Diseases by Signature Volatile Profiles

NCT02931032 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-10-12

No results posted yet for this study

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.

Conditions

  • Caries
  • Periodontitis

Interventions

PROCEDURE

Sampling of dental plaque / infected dentine

A sample of dental plaque / infected dentine will be taken during routine dental treatment and cultivated in a lab. The headspace above the culture will be sampled and analyzed in GC-MS for the detection of unique volatile organic compounds emitted by the plaque components.

Sponsors & Collaborators

  • Technion, Israel Institute of Technology

    collaborator OTHER
  • Tel Aviv University

    collaborator OTHER
  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Yael Houri-Haddad, Prof. · Hadassah Medical Organization

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-07-31
Completion
2017-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931032 on ClinicalTrials.gov