Effect of Mouth Rinses in Oral Malodor

Study Overview
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Brief Summary
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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.

Official Title
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Masking and Therapeutic Effect of Different Mouth Rinses in Patients With Oral Malodor.

Conditions
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Halitosis

Intervention / Treatment
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* Other: Fluoride rinse
* Other: Halita
* Other: Meridol Halitosis
* Other: Water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fluoride rinse<br>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<br>* rinse with 15 ml for 1 minute<br>|
| Active Comparator: Halita<br>Halita is a CHX-containing benchmark product that has proven to be clinically effective against halitosis (Roldan et al, 2003) | Other: Halita<br>* rinsing with 15 ml for 1 minute<br>* Other names: - Halita, Dentaid Spain;|
| Active Comparator: Meridol Halitosis<br>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<br>* rinsing with 15 ml for 1 minute<br>* Other names: name of manufacturer:GABA International AG;|
| Sham Comparator: Water<br>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<br>* rinsing with 15ml for 1 minute<br>* Other names: bottled water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | after 15' and after 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | 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). | after 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral malodor, Halitosis, Bad Breath, Mouth rinses, Mouthwashes, Amine fluoride/Stannous fluoride, Zinc ions, Chlorhexidine