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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Gaba International AG
Information provided by (Responsible Party):
Marc Quirynen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01226251
First received: October 12, 2010
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Halitosis
Device: In vitro chair side test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: New "in Vitro" Diagnostic Test for Oral Malodour: First Prototype Evaluation

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 150
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)
Groups/Cohorts Assigned Interventions
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 Name: Strip tes for oral malodour GABA (still confidential)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226251

Contacts
Contact: Marc Quirynen, PhD, DDS +32 16 33 24 85 marc.quirynen@uzleuven.be
Contact: Jesica Dadamio, Master Bioch +32 16 34 72 82 jesica.dadamio@med.kuleuven.be

Locations
Belgium
Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven Recruiting
Leuven, Belgium, 3000
Contact: Marc Quirynen, PhD, DDS    +32 16 33 24 85    marc.quirynen@uzleuven.be   
Contact: Jesica Dadamio, Master Bioch    +32 16 34 72 82    jesica.dadamio@med.kuleuven.be   
Principal Investigator: Marc Quirynen, PhD, DDS         
Sub-Investigator: Jesica Dadamio, Master Bioch         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Gaba International AG
Investigators
Principal Investigator: Marc Quirynen, PhD, DDS University Hospitals Leuven
  More Information

No publications provided

Responsible Party: Marc Quirynen, PhD DDS, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01226251     History of Changes
Other Study ID Numbers: 20100914
Study First Received: October 12, 2010
Last Updated: October 1, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
oral malodour
halitosis
Subjects consulting a bad breath clinic

Additional relevant MeSH terms:
Halitosis
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 25, 2014