Halitosis
Conditions
Keywords
Oral malodor, Halitosis, Bad Breath, Mouth rinses, Mouthwashes, Amine fluoride/Stannous fluoride, Zinc ions, Chlorhexidine
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.
Interventions
OTHERFluoride rinse
rinse with 15 ml for 1 minute
OTHERHalita
rinsing with 15 ml for 1 minute
OTHERMeridol Halitosis
rinsing with 15 ml for 1 minute
OTHERWater
rinsing with 15ml for 1 minute
Sponsors
Gaba International AG
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline organoleptic score of breath (OLS) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline global level of volatile sulphur compounds (VSC) | after 15' and after 3 weeks | 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 | after 3 weeks | 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 | after 3 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Patients' opinion | after 3 weeks | 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. |
Countries
Belgium
Contacts
Primary ContactMarc Quirynen, PhD, DDS
Outcome results
None listed