Diagnosis of Common Oral Diseases by Signature Volatile Profiles

NCT02931032 | Unknown

• 1 other identifier: 0088-16-HMO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries; Periodontitis

Keywords

nano receptor; oral microbiology; dental caries; periodontal disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients of Student Dental clinic

EXPERIMENTAL

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.

Procedure: Sampling of dental plaque / infected dentine

Interventions

Sampling of dental plaque / infected dentine PROCEDURE

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.

Patients of Student Dental clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Smoking
• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Technion, Israel Institute of Technology: collaborator
• Tel Aviv University: collaborator

Study Sites (1)

Hadassah School of Dental Medicine

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Periodontitis; Dental Caries; Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases

Study Officials

• Yael Houri-Haddad, Prof.

  Hadassah Medical Organization

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Department of Prosthodontics, Faculty of Dental Medicine

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 12, 2016
• Study Start: November 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 12, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)