Status:
UNKNOWN
New "in Vitro" Diagnostic Test for Oral Malodour
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
Gaba International AG
Conditions:
Halitosis
Eligibility:
All Genders
18-75 years
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. Previo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01226251
Start Date
January 1 2011
End Date
March 1 2013
Last Update
October 2 2012
Active Locations (1)
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1
Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven
Leuven, Belgium, 3000