Effect of Mouth Rinses in Oral Malodor (MR2012)

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

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.

Study Overview

• Status: Unknown
• Conditions: Halitosis
• Intervention / Treatment: Other: Fluoride rinse; Other: Halita; Other: Meridol Halitosis; Other: Water

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Quirynen, PhD, DDS; Phone Number: +32 16 33 24 85; Email: marcquirynen@med.kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Department of Periodontology, KULeuven
    • Contact: Jesica Dadamio, Master Bioch; Phone Number: +32 16 347282; Email: jesica.dadamio@med.kuleuven.be
    • Sub-Investigator: Jesica Dadamio, Master Bioch
    • Sub-Investigator: Sophie De Geest, DDS
    • Principal Investigator: Marc Quirynen, PhD, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Fluoride rinse; 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; rinse with 15 ml for 1 minute
Active Comparator: Halita; Halita is a CHX-containing benchmark product that has proven to be clinically effective against halitosis (Roldan et al, 2003)	Other: Halita; rinsing with 15 ml for 1 minute; Other Names: - Halita mouthwash 500 ml. CN 323923.3; - Halita, Dentaid Spain
Active Comparator: Meridol Halitosis; 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; rinsing with 15 ml for 1 minute; Other Names: name of product meridol® HALITOSIS mouthrinse; GABA product number:266831; PDM number: 3*21750; name of manufacturer:GABA International AG
Sham Comparator: Water; 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; rinsing with 15ml for 1 minute; Other Names: bottled water

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' opinion	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.	after 3 weeks

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Gaba International AG
• Investigators: Principal Investigator: Marc Quirynen, PhD, DDS, Universitarie Ziekenhuis Leuven

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: J Breath Res. 2010 Jun;4(2):029101.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 11, 2012

Study Record Updates

• Last Update Posted (Estimate): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Oral malodor; Chlorhexidine; Halitosis; Mouthwashes; Bad Breath; Mouth rinses; Amine fluoride/Stannous fluoride; Zinc ions
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Halitosis; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: GASAS-1205X