New "in Vitro" Diagnostic Test for Oral Malodour (Striptest)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||New "in Vitro" Diagnostic Test for Oral Malodour: First Prototype Evaluation|
- Colour evaluation of the new chair side test [ Time Frame: Once (during the first consult to the clinic) ] [ Designated as safety issue: No ]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.
- Organoleptic evaluation (OS) [ Time Frame: Once (during the first consult to the clinic) ] [ Designated as safety issue: No ]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.
- Total VSC reading [ Time Frame: Once (during the first consult to the clinic) ] [ Designated as safety issue: No ]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.
- Specific VSC readings [ Time Frame: Once (during the first consult to the clinic) ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Subjects consulting a bad breath clinic at the Department of Periodontology, KULeuven
Device: In vitro chair side test
Colour evaluation of a strip
Other Name: Strip tes for oral malodour GABA (still confidential)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226251
|Contact: Marc Quirynen, PhD, DDS||+32 16 33 24 firstname.lastname@example.org|
|Contact: Jesica Dadamio, Master Bioch||+32 16 34 72 email@example.com|
|Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Marc Quirynen, PhD, DDS +32 16 33 24 85 firstname.lastname@example.org|
|Contact: Jesica Dadamio, Master Bioch +32 16 34 72 82 email@example.com|
|Principal Investigator: Marc Quirynen, PhD, DDS|
|Sub-Investigator: Jesica Dadamio, Master Bioch|
|Principal Investigator:||Marc Quirynen, PhD, DDS||University Hospitals Leuven|