Effect of Mouth Rinses in Oral Malodor

NCT01747226 | Unknown DMC

• 1 other identifier: GASAS-1205X
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Halitosis

Keywords

Oral malodor; Halitosis; Bad Breath; Mouth rinses; Mouthwashes; Amine fluoride/Stannous fluoride; Zinc ions; Chlorhexidine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change from baseline global level of volatile sulphur compounds (VSC)

  after 15' and after 3 weeks

• Change from baseline microbial load of saliva

  after 3 weeks

• Change from baseline microbial load of tongue coating

  after 3 weeks

Other Outcomes (1)

• Patients' opinion

  after 3 weeks

Study Arms (4)

Fluoride rinse

PLACEBO COMPARATOR

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

Halita

ACTIVE COMPARATOR

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

Other: Halita

Meridol Halitosis

ACTIVE COMPARATOR

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

Water

SHAM COMPARATOR

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

Interventions

Fluoride rinse OTHER

rinse with 15 ml for 1 minute

Fluoride rinse

Halita OTHER

rinsing with 15 ml for 1 minute

Also known as: - Halita mouthwash 500 ml. CN 323923.3, - Halita, Dentaid Spain

Halita

Meridol Halitosis OTHER

rinsing with 15 ml for 1 minute

Also known as: name of product meridol® HALITOSIS mouthrinse, GABA product number:266831, PDM number: 3*21750, name of manufacturer:GABA International AG

Meridol Halitosis

Water OTHER

rinsing with 15ml for 1 minute

Also known as: bottled water

Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Gaba International AG: collaborator

Study Sites (1)

Department of Periodontology, KULeuven

Leuven, 3000, Belgium

Location

Related 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.

  PMID: 19811581 BACKGROUND

• 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.

  PMID: 21383479 BACKGROUND

• 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.

  PMID: 21386207 BACKGROUND

MeSH Terms

Conditions

Halitosis

Interventions

Water; Drinking Water

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Marc Quirynen, PhD, DDS

  Universitarie Ziekenhuis Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Quirynen, PhD, DDS

CONTACT

+32 16 33 24 85; marcquirynen@med.kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD DDS

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 11, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

BE (1)