Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2011-01-31
2013-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy adults
Subjects consulting a bad breath clinic at the Department of Periodontology, KULeuven
In vitro chair side test
Colour evaluation of a strip
Interventions
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In vitro chair side test
Colour evaluation of a strip
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Gaba International AG
INDUSTRY
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Marc Quirynen
PhD DDS
Principal Investigators
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Marc Quirynen, PhD, DDS
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Marc Quirynen, PhD, DDS
Role: primary
Jesica Dadamio, Master Bioch
Role: backup
Other Identifiers
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20100914
Identifier Type: -
Identifier Source: org_study_id