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Effect of Mouth Rinses in Oral Malodor (MR2012)

Primary Purpose

Halitosis

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Fluoride rinse
Halita
Meridol Halitosis
Water
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis focused on measuring Oral malodor, Halitosis, Bad Breath, Mouth rinses, Mouthwashes, Amine fluoride/Stannous fluoride, Zinc ions, Chlorhexidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Periodontology, KULeuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Fluoride rinse

Halita

Meridol Halitosis

Water

Arm Description

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.

Halita is a CHX-containing benchmark product that has proven to be clinically effective against halitosis (Roldan et al, 2003)

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).

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.

Outcomes

Primary Outcome Measures

Change from baseline organoleptic score of breath (OLS)
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
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)
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
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
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).

Full Information

First Posted
December 5, 2012
Last Updated
December 10, 2012
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Gaba International AG
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1. Study Identification

Unique Protocol Identification Number
NCT01747226
Brief Title
Effect of Mouth Rinses in Oral Malodor
Acronym
MR2012
Official Title
Masking and Therapeutic Effect of Different Mouth Rinses in Patients With Oral Malodor.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
Gaba International AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
Oral malodor, Halitosis, Bad Breath, Mouth rinses, Mouthwashes, Amine fluoride/Stannous fluoride, Zinc ions, Chlorhexidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluoride rinse
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Halita
Arm Type
Active Comparator
Arm Description
Halita is a CHX-containing benchmark product that has proven to be clinically effective against halitosis (Roldan et al, 2003)
Arm Title
Meridol Halitosis
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Water
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fluoride rinse
Intervention Description
rinse with 15 ml for 1 minute
Intervention Type
Other
Intervention Name(s)
Halita
Other Intervention Name(s)
- Halita mouthwash 500 ml. CN 323923.3, - Halita, Dentaid Spain
Intervention Description
rinsing with 15 ml for 1 minute
Intervention Type
Other
Intervention Name(s)
Meridol Halitosis
Other Intervention Name(s)
name of product meridol® HALITOSIS mouthrinse, GABA product number:266831, PDM number: 3*21750, name of manufacturer:GABA International AG
Intervention Description
rinsing with 15 ml for 1 minute
Intervention Type
Other
Intervention Name(s)
Water
Other Intervention Name(s)
bottled water
Intervention Description
rinsing with 15ml for 1 minute
Primary Outcome Measure Information:
Title
Change from baseline organoleptic score of breath (OLS)
Description
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.
Time Frame
after15' and after 3 weeks
Title
Change from baseline in H2S and CH3SH level in breath
Description
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.
Time Frame
after 15' and after 3 weeks
Secondary Outcome Measure Information:
Title
Change from baseline global level of volatile sulphur compounds (VSC)
Description
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
Time Frame
after 15' and after 3 weeks
Title
Change from baseline microbial load of saliva
Description
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).
Time Frame
after 3 weeks
Title
Change from baseline microbial load of tongue coating
Description
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).
Time Frame
after 3 weeks
Other Pre-specified Outcome Measures:
Title
Patients' opinion
Description
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.
Time Frame
after 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Quirynen, PhD, DDS
Phone
+32 16 33 24 85
Email
marcquirynen@med.kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Quirynen, PhD, DDS
Organizational Affiliation
Universitarie Ziekenhuis Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology, KULeuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesica Dadamio, Master Bioch
Phone
+32 16 347282
Email
jesica.dadamio@med.kuleuven.be
First Name & Middle Initial & Last Name & Degree
Jesica Dadamio, Master Bioch
First Name & Middle Initial & Last Name & Degree
Sophie De Geest, DDS
First Name & Middle Initial & Last Name & Degree
Marc Quirynen, PhD, DDS

12. IPD Sharing Statement

Citations:
PubMed Identifier
19811581
Citation
Quirynen M, Dadamio J, Van den Velde S, De Smit M, Dekeyser C, Van Tornout M, Vandekerckhove B. Characteristics of 2000 patients who visited a halitosis clinic. J Clin Periodontol. 2009 Nov;36(11):970-5. doi: 10.1111/j.1600-051X.2009.01478.x. Epub 2009 Oct 6.
Results Reference
background
PubMed Identifier
21383479
Citation
Wilhelm D, Gysen K, Himmelmann A, Krause C, Wilhelm KP. Short-term effect of a new mouthrinse formulation on oral malodour after single use in vivo: a comparative, randomized, single-blind, parallel-group clinical study. J Breath Res. 2010 Sep;4(3):036002. doi: 10.1088/1752-7155/4/3/036002. Epub 2010 Aug 17.
Results Reference
background
PubMed Identifier
21386207
Citation
Wigger-Alberti W, Gysen K, Axmann EM, Wilhelm KP. Efficacy of a new mouthrinse formulation on the reduction of oral malodour in vivo. A randomized, double-blind, placebo-controlled, 3 week clinical study. J Breath Res. 2010 Mar;4(1):017102. doi: 10.1088/1752-7155/4/1/017102. Epub 2009 Dec 18. Erratum In: J Breath Res. 2010 Jun;4(2):029101.
Results Reference
background

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Effect of Mouth Rinses in Oral Malodor

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