Effect of Mouth Rinses in Oral Malodor

Halitosis Clinical Trial

— MR2012  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01747226
• Other study ID #: GASAS-1205X
• Status: Not yet recruiting
• Phase: N/A
• First received: December 5, 2012
• Last updated: December 10, 2012
• Start date: March 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2012
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Marc Quirynen, PhD, DDS
• Phone: +32 16 33 24 85
• Email: marcquirynen[@]med.kuleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Halitosis

Intervention

Other:
• Fluoride rinse
rinse with 15 ml for 1 minute
• Halita
rinsing with 15 ml for 1 minute
• Meridol Halitosis
rinsing with 15 ml for 1 minute
• Water
rinsing with 15ml for 1 minute

Locations

Country	Name	City	State
Belgium	Department of Periodontology, KULeuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	Gaba International AG

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View 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. Erratum in: J Breath Res. 2010 Jun;4(2):029101. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No