Effect of Mouth Rinses in Oral Malodor (MR2012)

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Halitosis

Treatments: Other: Water; Other: Meridol Halitosis; Other: Fluoride rinse; Other: Halita

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01747226

GASAS-1205X

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 4 patient groups, including a placebo group

Fluoride rinse

Placebo Comparator group

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.

Treatment:

Other: Fluoride rinse

Halita

Active Comparator group

Description:

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

Treatment:

Other: Halita

Meridol Halitosis

Active Comparator group

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).

Treatment:

Other: Meridol Halitosis

Water

Sham Comparator group

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.

Treatment:

Other: Water