New "in Vitro" Diagnostic Test for Oral Malodour | NCT01226251

Studies
New "in Vitro" Diagnostic Test for Oral Malodour

NCT01226251

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Unknown status

Last Update Posted

Oct 2, 2012Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Halitosis

Interventions

In vitro chair side test

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Oct 12, 2010

First Submission Date that Met QC Criteria

Oct 21, 2010

First Posted Date

Oct 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2012

Last Update Posted Date

Oct 2, 2012Estimated

Name	Class
Gaba International AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy adults		Subjects consulting a bad breath clinic at the Department of Periodontology, KULeuven	Device: In vitro chair side test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
In vitro chair side test	Device	Colour evaluation of a strip	Healthy adults

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Marc Quirynen, PhD, DDS	Universitaire Ziekenhuizen KU Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven	Recruiting	Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D006209	Halitosis

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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