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

1. oktober 2012 opdateret af: Marc Quirynen, Universitaire Ziekenhuizen KU Leuven

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Forventet)

150

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Leuven, Belgien, 3000
        • Rekruttering
        • Department of Periodontology, Faculty of Dentistry, Catholic University of Leuven
        • Underforsker:
          • Jesica Dadamio, Master Bioch
        • Ledende efterforsker:
          • Marc Quirynen, PhD, DDS
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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)

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Healthy adults
Subjects consulting a bad breath clinic at the Department of Periodontology, KULeuven
Enhed: In vitro chair side test
Colour evaluation of a strip
Andre navne:
  • Strip tes for oral malodour GABA (still confidential)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Colour evaluation of the new chair side test
Tidsramme: 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.
Once (during the first consult to the clinic)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Organoleptic evaluation (OS)
Tidsramme: Once (during the first consult to the clinic)
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.
Once (during the first consult to the clinic)
Total VSC reading
Tidsramme: Once (during the first consult to the clinic)
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.
Once (during the first consult to the clinic)
Specific VSC readings
Tidsramme: Once (during the first consult to the clinic)
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.
Once (during the first consult to the clinic)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Samarbejdspartnere

Gaba International AG

Efterforskere

  • Ledende efterforsker: Marc Quirynen, PhD, DDS, Universitaire Ziekenhuizen KU Leuven

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Forventet)

1. december 2012

Studieafslutning (Forventet)

1. marts 2013

Datoer for studieregistrering

Først indsendt

12. oktober 2010

Først indsendt, der opfyldte QC-kriterier

21. oktober 2010

Først opslået (Skøn)

22. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. oktober 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. oktober 2012

Sidst verificeret

1. oktober 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20100914

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Halitosis

Kliniske forsøg med In vitro chair side test

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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