Trial record 5 of 7 for:    Open Studies | "Halitosis"

Effect of Mouth Rinses in Oral Malodor (MR2012)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Collaborator:
Gaba International AG
Information provided by (Responsible Party):
Marc Quirynen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01747226
First received: December 5, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

Bad breath or halitosis is caused by specific gases originating from the mouth or the expired air. In most cases the pathology lies within the mouth and in this case receives the name pathologic halitosis of oral cause or oral malodor. The aim of this study is to evaluate the immediate (masking) and long term (therapeutic) effect of commercially available mouth rinses in the treatment of oral malodor. For this volunteers with oral malodor detected by organoleptic evaluation and confirmed by the increase level of sulphur compounds in their breath (VSC) will be asked to use a designated mouthwash. The breath parameters will be assessed at baseline and 15' after the first rinse (15 ml, during 1 minute) and over night at the end of a period of 3 weeks during which the volunteers rinsed twice a day (15 ml, 1 minute) with the assigned mouthwash. The short and long term effect of a stannous fluoride/amine fluoride/zinc rinse; a chlorhexidine/cetylpyridinium chloride/zinc product and a negative control(fluoride rinse and/or water) will be compared.


Condition Intervention
Halitosis
Other: Fluoride rinse
Other: Halita
Other: Meridol Halitosis
Other: Water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Masking and Therapeutic Effect of Different Mouth Rinses in Patients With Oral Malodor.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Change from baseline organoleptic score of breath (OLS) [ Time Frame: after15' and after 3 weeks ] [ Designated as safety issue: No ]
    A trained and calibrated "judge" sniffs the expired air of the volunteer and assesses whether it is unpleasant by using an intensity rating, normally from 0 to 5, with 0 = no odor present, 1 = barely noticeable odor, 2 = slight but clearly noticeable odor, 3 = moderate odor, 4 = strong offensive odor, and 5 = extremely foul odor (proposed by Rosenberg and McCulloch.

  • Change from baseline in H2S and CH3SH level in breath [ Time Frame: after 15' and after 3 weeks ] [ Designated as safety issue: No ]
    A portable gas chromatograph (OralChroma™, Abilit Corporation, Kanagawa, Japan) will be used to measures the concentration of hydrogen sulphur (H2S) and methyl mercaptan (CH3SH) in mouth air. The device has been calibrated and validated for its use by the manufacturer.


Secondary Outcome Measures:
  • Change from baseline global level of volatile sulphur compounds (VSC) [ Time Frame: after 15' and after 3 weeks ] [ Designated as safety issue: No ]
    A portable device (Halimeter®, Interscan Corporation, model RH-17E, Chatsworth, USA)able to detect sulphur compounds in air will be used according to the manufacturer instructions

  • Change from baseline microbial load of saliva [ Time Frame: after 3 weeks ] [ Designated as safety issue: No ]
    A sample of non-stimulated saliva will be collected into a sterile container and kept at 4°C till processing. To the standard culture of the samples (of aerobic and anaerobic incubation at 37°C) a molecular technique (qPCR)of bacterial detection will be added for periodontal pathogens (P. gingivalis, P intermedia, F. nucleatum and A. actinomycetemcomitans) and bacteria usually involved in oral malodour (S. moorei).

  • Change from baseline microbial load of tongue coating [ Time Frame: after 3 weeks ] [ Designated as safety issue: No ]
    Tongue coating will be collected by wiping a sterile swab 3 times over the dorsum of the tongue, in the area of the foramen caecum. Till analysis; the tip of the cotton swab will be kept in a vial containing 2ml of reduced transport fluid (RTF). To the standard culture of the samples (of aerobic and anaerobic incubation at 37°C) a molecular technique (qPCR)of bacterial detection will be added for periodontal pathogens (P. gingivalis, P intermedia, F. nucleatum and A. actinomycetemcomitans) and bacteria usually involved in oral malodour (S. moorei).


Other Outcome Measures:
  • Patients' opinion [ Time Frame: after 3 weeks ] [ Designated as safety issue: No ]
    Patients' opinion regarding product satisfaction will be scored on a VAS line (0 to 10). The questionnaire will include the following points:satisfaction, side effects, use, future use and effectiveness.


Estimated Enrollment: 96
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fluoride rinse
A fluoride rinse with alcohol was chosen because its similarity in color and aroma to the active rinses. This anti-cavity rinse does not contain any active components and therefore it is not expected to have any anti-malodour activity.
Other: Fluoride rinse
rinse with 15 ml for 1 minute
Active Comparator: Halita
Halita is a CHX-containing benchmark product that has proven to be clinically effective against halitosis (Roldan et al, 2003)
Other: Halita
rinsing with 15 ml for 1 minute
Other Names:
  • - Halita mouthwash 500 ml. CN 323923.3
  • - Halita, Dentaid Spain
Active Comparator: Meridol Halitosis
This study aims to confirm the effect of meridol®Halitosis(AmF/SnF2 and zinc) already observed in volunteers with morning bad breath (physiological)(Wigger-Alberti et al, 2010; Wilhelm et al, 2010)in patients with oral malodor (pathological).
Other: Meridol Halitosis
rinsing with 15 ml for 1 minute
Other Names:
  • name of product meridol® HALITOSIS mouthrinse
  • GABA product number:266831
  • PDM number: 3*21750
  • name of manufacturer:GABA International AG
Sham Comparator: Water
To distinguish the masking effect caused by the formulations and the one caused by the rinsing itself.Only for short term evaluation (15') to not to compromise compliance of patients.
Other: Water
rinsing with 15ml for 1 minute
Other Name: bottled water

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Caucasian
  • Age ≥ 18 years
  • Organoleptic score of breath ≥ 2
  • VSC readings (sum of H2S and CH3SH by OralChroma) ≥ 120 ppb*
  • Intra-oral cause of bad breath
  • Non-smokers
  • Willing to participate and able to give written informed consent

Exclusion Criteria:

  • Ongoing dental treatment or any other medical treatment of the oral cavity
  • Any known allergy to previously used oral hygiene products or any known allergy to any of the ingredients of the study products, which are used during the study
  • Any pathological change of the oral mucosa
  • Use of prohibited treatments / therapies and/or abuse of drugs, alcohol, etc
  • Pregnancy or breastfeeding
  • Active caries
  • Acute sinusitis
  • Severe oro-pharyngeal infections
  • On medications which can cause malodour
  • Reduced salivary flow due to pathological reasons (e.g. Sjögren syndrome)
  • Situation considered not compatible with the study according to the investigator's opinion; the latter includes: patients eating very spicy food, 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.
  • Patients unwilling to abstain from additional oral hygiene (only toothbrushing allowed) particularly mouthrinse, chewing gums, breath strips, etc
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747226

Contacts
Contact: Marc Quirynen, PhD, DDS +32 16 33 24 85 marcquirynen@med.kuleuven.be

Locations
Belgium
Department of Periodontology, KULeuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Jesica Dadamio, Master Bioch    +32 16 347282    jesica.dadamio@med.kuleuven.be   
Sub-Investigator: Jesica Dadamio, Master Bioch         
Sub-Investigator: Sophie De Geest, DDS         
Principal Investigator: Marc Quirynen, PhD, DDS         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Gaba International AG
Investigators
Principal Investigator: Marc Quirynen, PhD, DDS Universitarie Ziekenhuis Leuven
  More Information

Publications:
Responsible Party: Marc Quirynen, PhD DDS, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01747226     History of Changes
Other Study ID Numbers: GASAS-1205X
Study First Received: December 5, 2012
Last Updated: December 10, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Oral malodor
Halitosis
Bad Breath
Mouth rinses
Mouthwashes
Amine fluoride/Stannous fluoride
Zinc ions
Chlorhexidine

Additional relevant MeSH terms:
Halitosis
Signs and Symptoms, Digestive
Signs and Symptoms
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014