New "in Vitro" Diagnostic Test for Oral Malodour (Striptest)

Universitaire Ziekenhuizen KU Leuven

Status

Unknown

Conditions

Halitosis

Treatments

Device: In vitro chair side test

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT01226251

20100914

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adults (≥18 years
With no evidence of bad breath or bad breath of intra-oral cause (oral malodour)
Non-smokers or smokers from whom the organoleptic evaluation can be performed (no interference from smoke odour)

Exclusion criteria

Smokers from whom the organoleptic evaluation can not be performed because of interference from smoke odour
Presence of active caries
Presence of sinusitis or any other Oro-pharyngeal problem
On medications which can cause malodour
Reduced salivary flow due to pathological reasons (e.g. Sjögren syndrome)
Any oral pathophysiological condition or any oral disease (e.g. oral cancer, mucositis)
Pregnancy and nursing
Situation considered not compatible with the study according to the investigator's opinion; the latter includes: persons under homeopathic therapy, patients who used antibiotics during the 2 months before the study, patients frequently using chewing gum, patients under corticosteroids or other serious medications.