Clinical trial NCT01747226: Effect of Mouth Rinses in Oral Malodor
Official title: Masking and Therapeutic Effect of Different Mouth Rinses in Patients With Oral Malodor.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Halitosis
Keywords: Oral malodor
Halitosis
Bad Breath
Mouth rinses
Mouthwashes
Amine fluoride/Stannous fluoride
Zinc ions
Chlorhexidine
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: Gaba International AG
First posted: 2012-12-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline organoleptic score of breath (OLS)
timeFrame: after15' and after 3 weeks
measure: Change from baseline in H2S and CH3SH level in breath
timeFrame: after 15' and after 3 weeks
Secondary outcomes:
measure: Change from baseline global level of volatile sulphur compounds (VSC)
timeFrame: after 15' and after 3 weeks
measure: Change from baseline microbial load of saliva
timeFrame: after 3 weeks
measure: Change from baseline microbial load of tongue coating
timeFrame: after 3 weeks
Other outcomes:
measure: Patients' opinion
timeFrame: after 3 weeks
Locations:
city: Leuven
country: Belgium
facility: Department of Periodontology, KULeuven
Study officials:
affiliation: Universitarie Ziekenhuis Leuven
name: Marc Quirynen, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wilhelm 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.
citation: Wigger-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.