- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01226251
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.
Panoramica dello studio
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Leuven, Belgio, 3000
- Reclutamento
- Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven
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Sub-investigatore:
- Jesica Dadamio, Master Bioch
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Investigatore principale:
- Marc Quirynen, PhD, DDS
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Contatto:
- Marc Quirynen, PhD, DDS
- Numero di telefono: +32 16 33 24 85
- Email: marc.quirynen@uzleuven.be
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Contatto:
- Jesica Dadamio, Master Bioch
- Numero di telefono: +32 16 34 72 82
- Email: jesica.dadamio@med.kuleuven.be
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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)
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Healthy adults
Subjects consulting a bad breath clinic at the Department of Periodontology, KULeuven
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Colour evaluation of a strip
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Colour evaluation of the new chair side test
Lasso di tempo: Once (during the first consult to the clinic)
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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.
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Once (during the first consult to the clinic)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Organoleptic evaluation (OS)
Lasso di tempo: Once (during the first consult to the clinic)
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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.
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Once (during the first consult to the clinic)
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Total VSC reading
Lasso di tempo: Once (during the first consult to the clinic)
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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.
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Once (during the first consult to the clinic)
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Specific VSC readings
Lasso di tempo: Once (during the first consult to the clinic)
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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.
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Once (during the first consult to the clinic)
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Marc Quirynen, PhD, DDS, Universitaire Ziekenhuizen KU Leuven
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 20100914
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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