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New "in Vitro" Diagnostic Test for Oral Malodour

NCT01226251 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2012-10-02

No results posted yet for this study

Summary

This study will assess the ability of a first prototype (strip) of a new chair side test to detect oral malodour. The strip is based on a new enzymatic reaction able to detect amines in saliva. Previous studies already showed significant correlations between oral malodor and the levels of amines in saliva. The limitation in their use as markers of oral malodour is the fact that the detection is usually carried out by complex techniques (High Performance Liquid Chromatography(HPLC)and Solid-Phase Micro Extraction-Gas Chromatography/Mass Spectrometry (SPME-GC/MS)). The results of the new enzymatic reaction can be evaluated by means of a colorimetric scale without necessity of extra apparatus.

The study will be carried out with volunteers recruited at a multidisciplinary consultation for bad breath, organized at the University Hospital Leuven, Belgium.

The paper strip will be used before the routine evaluation (organoleptic score (OS), the gold standard method for the diagnosis of halitosis and the level of volatile sulphur compounds (VSC), the most used adjunct tool to diagnose halitosis).

The results of the new chair side test (strip) will be correlated with the OS and VSC measurements (OralChroma™, Halimeter®). The sensitivity, specificity and positive and negative predicted values of the new chair side test will be calculated. The cut-off values for a yes/no test will be determined. The meaning of color scores will be analyzed to assign a meaningful outcome to each score with relation to odor intensity.

Conditions

  • Halitosis

Interventions

DEVICE

In vitro chair side test

Colour evaluation of a strip

Sponsors & Collaborators

  • Gaba International AG

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Marc Quirynen, PhD, DDS · Universitaire Ziekenhuizen KU Leuven

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • Belgium

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 NCT01226251 on ClinicalTrials.gov