Loading search results
Sponsor study identifier
interventional
100
1 country
1
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 5, 2016
Actual (reported)October 12, 2016
Actual (reported)November 2016
Date type not reportedThis date has not been verified as actual or estimated.
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Volatile Molecular Concentration of the Headspace Samples
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.
48 hours
Enrolled patients of the student dental clinic in Hadassah Faculty of Dental Medicine, who came to receive scheduled dental treatment and agreed to participate in the trial. The patients sampled will originate at the students' clinics, and the samples will be taken as part of their dental treatment, namely: removal of caries and infected dentin for future restoration, and dental calculus and plaque removal for the treatment of periodontal disease.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hadassah School of Dental Medicine
Jerusalem, 91120, Israel
Yael Houri-Haddad, Prof.
Hadassah Medical Organization
First Submitted
October 5, 2016
First Posted
October 12, 2016
Study Start
November 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 12, 2016
Record last verified: 2016-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: