Effect of Mouth Rinses in Oral Malodor (MR2012)
Halitosis
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
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
Placebo Comparator
Active Comparator
Active Comparator
Sham Comparator
Fluoride rinse
Halita
Meridol Halitosis
Water
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.