Halitosis Clinical Trial
Official title:
New "in Vitro" Diagnostic Test for Oral Malodour: First Prototype Evaluation
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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