New "in Vitro" Diagnostic Test for Oral Malodour (Striptest)

New "in Vitro" Diagnostic Test for Oral Malodour: First Prototype Evaluation

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 Overview

• Status: Unknown
• Conditions: Halitosis
• Intervention / Treatment: Device: In vitro chair side test

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven
    • Sub-Investigator: Jesica Dadamio, Master Bioch
    • Principal Investigator: Marc Quirynen, PhD, DDS
    • Contact: Marc Quirynen, PhD, DDS; Phone Number: +32 16 33 24 85; Email: marc.quirynen@uzleuven.be
    • Contact: Jesica Dadamio, Master Bioch; Phone Number: +32 16 34 72 82; Email: jesica.dadamio@med.kuleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy adults; Subjects consulting a bad breath clinic at the Department of Periodontology, KULeuven	Device: In vitro chair side test; Colour evaluation of a strip; Other Names: Strip tes for oral malodour GABA (still confidential)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Once (during the first consult to the clinic)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Once (during the first consult to the clinic)

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Gaba International AG
• Investigators: Principal Investigator: Marc Quirynen, PhD, DDS, Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 21, 2010
• First Posted (Estimate): October 22, 2010

Study Record Updates

• Last Update Posted (Estimate): October 2, 2012
• Last Update Submitted That Met QC Criteria: October 1, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: halitosis; oral malodour; Subjects consulting a bad breath clinic
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Halitosis
• Other Study ID Numbers: 20100914