HalitosisStriptestNCT01226251
New "in Vitro" Diagnostic Test for Oral Malodour
An observational study of Halitosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- In vitro chair side test
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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)
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven
Leuven, 3000
Marc Quirynen, PhD, DDS, +32 16 33 24 85, marc.quirynen@uzleuven.be
Jesica Dadamio, Master Bioch, +32 16 34 72 82, jesica.dadamio@med.kuleuven.be
About this study
Official title: 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.
Read more
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
- Being tested
- In vitro chair side test
- Keywords
- oral malodour, halitosis, Subjects consulting a bad breath clinic
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vitro chair side testDevice
Also called Strip tes for oral malodour GABA (still confidential)
Colour evaluation of a strip
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Subjects consulting a bad breath clinic at the Department of Periodontology, KULeuven Receives: Device: In vitro chair side test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once (during the first consult to the clinic)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Once (during the first consult to the clinic)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HalitosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Gaba International AG
- Responsible party
- Principal investigator, Marc Quirynen, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Marc Quirynen, PhD, DDS, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226251
- Sponsor's protocol ID
- 20100914
- Acronym
- Striptest
- Status last verified
- Oct 2012
- First submitted
- 12 Oct 2010
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New "in Vitro" Diagnostic Test for Oral Malodour: First Prototype Evaluation
- ClinicalTrials.gov ID
- NCT01226251
- Acronym / sponsor ID
- Striptest / 20100914
- Conditions
- Halitosis
- Keywords
- oral malodour, halitosis, Subjects consulting a bad breath clinic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Gaba International AG
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Device: In vitro chair side testSubjects consulting a bad breath clinic at the Department of Periodontology, KULeuven |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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)
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In vitro chair side testAlso: Strip tes for oral malodour GABA (still confidential)Colour evaluation of a strip | Device | Healthy adults |
Primary outcome
Colour evaluation of the new chair side test
Time frame: Once (during the first consult to the clinic)
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.
3 secondary outcomes
Organoleptic evaluation (OS)
Time frame: Once (during the first consult to the clinic)
Total VSC reading
Time frame: Once (during the first consult to the clinic)
Specific VSC readings
Time frame: Once (during the first consult to the clinic)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Quirynen, PhD, DDS principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Halitosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Quirynen, PhD, DDS (+32 16 33 24 85, marc.quirynen@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colour evaluation of the new chair side test (time frame: Once (during the first consult to the clinic)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2012.