Clinical trial NCT01226251: New "in Vitro" Diagnostic Test for Oral Malodour
Official title: New "in Vitro" Diagnostic Test for Oral Malodour: First Prototype Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Halitosis
Keywords: oral malodour
halitosis
Subjects consulting a bad breath clinic
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Gaba International AG
First posted: 2010-10-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hundred consecutive adult subjects consulting the bad breath clinic who meet the inclusion criteria.

Number of volunteers extended to 150 in March 2012 (Amendment Research Agreement)

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Colour evaluation of the new chair side test
timeFrame: Once (during the first consult to the clinic)
Secondary outcomes:
measure: Organoleptic evaluation (OS)
timeFrame: Once (during the first consult to the clinic)
measure: Total VSC reading
timeFrame: Once (during the first consult to the clinic)
measure: Specific VSC readings
timeFrame: Once (during the first consult to the clinic)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Marc Quirynen, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References: