HalitosisMR2012NCT01747226
Effect of Mouth Rinses in Oral Malodor
A study testing Fluoride rinse, Halita and Meridol Halitosis in people with Halitosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- Fluoride rinse, Halita and Meridol Halitosis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2013to Dec 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Periodontology, KULeuven
Leuven, 3000
Jesica Dadamio, Master Bioch, +32 16 347282, jesica.dadamio@med.kuleuven.be
Jesica Dadamio, Master Bioch
About this study
Official title: Masking and Therapeutic Effect of Different Mouth Rinses in Patients With Oral Malodor.
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride rinseOther
rinse with 15 ml for 1 minute
HalitaOther
Also called - Halita mouthwash 500 ml. CN 323923.3, - Halita, Dentaid Spain
rinsing with 15 ml for 1 minute
Meridol HalitosisOther
Also called name of product meridol® HALITOSIS mouthrinse, GABA product number:266831, PDM number: 3*21750, name of manufacturer:GABA International AG
rinsing with 15 ml for 1 minute
WaterOther
Also called bottled water
rinsing with 15ml for 1 minute
| Study group | Role | What they receive |
|---|---|---|
| Fluoride rinse | Placebo comparator | 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. Receives: Other: Fluoride rinse |
| Halita | Active comparator | Halita is a CHX-containing benchmark product that has proven to be clinically effective against halitosis (Roldan et al, 2003) Receives: Other: Halita |
| Meridol Halitosis | Active comparator | 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). Receives: Other: Meridol Halitosis |
| Water | Sham comparator | 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. Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after15' and after 3 weeks
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.
Measured: after 15' and after 3 weeks
Secondary outcomes (3)
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
Measured: after 15' and after 3 weeks
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).
Measured: after 3 weeks
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).
Measured: after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 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, Universitarie Ziekenhuis Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747226
- Sponsor's protocol ID
- GASAS-1205X
- Acronym
- MR2012
- Status last verified
- Dec 2012
- First submitted
- 5 Dec 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19811581Wilhelm 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.
PubMed 21383479Wigger-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.
PubMed 21386207
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Masking and Therapeutic Effect of Different Mouth Rinses in Patients With Oral Malodor.
- ClinicalTrials.gov ID
- NCT01747226
- Acronym / sponsor ID
- MR2012 / GASAS-1205X
- Conditions
- Halitosis
- Keywords
- Oral malodor, Halitosis, Bad Breath, Mouth rinses, Mouthwashes, Amine fluoride/Stannous fluoride, Zinc ions, Chlorhexidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Gaba International AG
- Study start
- Mar 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 11 Dec 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fluoride rinse | Placebo comparator | Other: Fluoride rinseA 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 | Active comparator | Other: HalitaHalita is a CHX-containing benchmark product that has proven to be clinically effective against halitosis (Roldan et al, 2003) |
| Meridol Halitosis | Active comparator | Other: Meridol HalitosisThis 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). |
| Water | Sham comparator | Other: WaterTo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| Fluoride rinserinse with 15 ml for 1 minute | Other | Fluoride rinse |
| HalitaAlso: - Halita mouthwash 500 ml. CN 323923.3, - Halita, Dentaid Spainrinsing with 15 ml for 1 minute | Other | Halita |
| Meridol HalitosisAlso: name of product meridol® HALITOSIS mouthrinse, GABA product number:266831, PDM number: 3*21750, name of manufacturer:GABA International AGrinsing with 15 ml for 1 minute | Other | Meridol Halitosis |
| WaterAlso: bottled waterrinsing with 15ml for 1 minute | Other | Water |
Primary outcome
Change from baseline organoleptic score of breath (OLS)
Time frame: after15' and after 3 weeks
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
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.
3 secondary outcomes
Change from baseline global level of volatile sulphur compounds (VSC)
Time frame: after 15' and after 3 weeks
Change from baseline microbial load of saliva
Time frame: after 3 weeks
Change from baseline microbial load of tongue coating
Time frame: after 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
- Background: PubMed 19811581Quirynen 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.
- Background: PubMed 21383479Wilhelm 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.
- Background: PubMed 21386207Wigger-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.
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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
Universitarie Ziekenhuis Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoride rinse, Halita and Meridol Halitosis in people with 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 7 inclusion and 12 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 11 Dec 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. Some participants in this study may receive a placebo. 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, marcquirynen@med.kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline organoleptic score of breath (OLS) (time frame: after15' and after 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01747226, which also lists 3 linked publications.
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 11 Dec 2012.