New "in Vitro" Diagnostic Test for Oral Malodour

NCT01226251 | Unknown DMC

• 1 other identifier: 20100914
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Halitosis

Keywords

oral malodour; halitosis; Subjects consulting a bad breath clinic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Organoleptic evaluation (OS)

  Once (during the first consult to the clinic)

• Total VSC reading

  Once (during the first consult to the clinic)

• Specific VSC readings

  Once (during the first consult to the clinic)

Study Arms (1)

Healthy adults

Subjects consulting a bad breath clinic at the Department of Periodontology, KULeuven

Device: In vitro chair side test

Interventions

In vitro chair side test DEVICE

Colour evaluation of a strip

Also known as: Strip tes for oral malodour GABA (still confidential)

Healthy adults

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Gaba International AG: collaborator

Study Sites (1)

Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Halitosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Quirynen, PhD, DDS

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Quirynen, PhD, DDS

CONTACT

+32 16 33 24 85; marc.quirynen@uzleuven.be

Jesica Dadamio, Master Bioch

CONTACT

+32 16 34 72 82; jesica.dadamio@med.kuleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD DDS

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 22, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 2, 2012

Record last verified: 2012-10

Locations

BE (1)