An observational study in Halitosis, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-02.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
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.
90 studies on the registry are indexed under Halitosis; 18 are open to participants now.
This study's planned enrollment of 150 is above the median of 89 across 12 observational studies indexed under Halitosis.
Browse Halitosis studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 958 studies on the registry; 263 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects consulting a bad breath clinic at the Department of Periodontology, KULeuven
Device: In vitro chair side test
Colour evaluation of a strip
Also known as: Strip tes for oral malodour GABA (still confidential)
Colour evaluation of the new chair side test
The colour will be assessed before all the other test and after 4 minutes of contact between the strip and the saliva of the volunteer.
Time frame: Once (during the first consult to the clinic)
Organoleptic evaluation (OS)
The OS will be determined by a trained and calibrated judge as described in the literature. Briefly, patients will be asked to count from one to eleven and the judge rated the exhaled air on a 0 to 5 score ( 0 represents absence of odour, 1 is given for barely noticeable odour, 2 for slight malodor, 3 for moderate malodor, 4 for strong malodor and 5 for severe malodor). The judge will also evaluate nasal breath in order to exclude extra-oral causes of halitosis and the odor of a sample of the tongue coating, if present.
Time frame: Once (during the first consult to the clinic)
Total VSC reading
The global concentration of sulphur containing compounds will be measured using a portable breath analyzer (Halimeter®, Interscan cooperation, Chatsworth, US. The maximum level attained (ppb) is determined by direct readings from the analog scale of the monitor.
Time frame: Once (during the first consult to the clinic)
Specific VSC readings
Hydrogen sulphide, methyl mercaptan and dimethyl sulphide will be measured using a commercially available system (OralChroma™, Abilit Corporation; Osaka City, Japan). This portable gas chromatograph is equipped with an indium oxide semiconductor gas sensor. The concentration values (ppbv) of the three gases will be recorded.
Time frame: Once (during the first consult to the clinic)
This study is status unknown, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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