Effect of Mouth Rinses in Oral Malodor (MR2012)
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|ClinicalTrials.gov Identifier: NCT01747226|
Recruitment Status : Unknown
Verified December 2012 by Marc Quirynen, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Not yet recruiting
First Posted : December 11, 2012
Last Update Posted : December 11, 2012
|Condition or disease||Intervention/treatment||Phase|
|Halitosis||Other: Fluoride rinse Other: Halita Other: Meridol Halitosis Other: Water||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Masking and Therapeutic Effect of Different Mouth Rinses in Patients With Oral Malodor.|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||December 2015|
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)
rinsing with 15 ml for 1 minute
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
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.
rinsing with 15ml for 1 minute
Other Name: bottled water
- Change from baseline organoleptic score of breath (OLS) [ Time Frame: after15' and after 3 weeks ]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.
- Change from baseline in H2S and CH3SH level in breath [ Time Frame: after 15' and after 3 weeks ]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.
- Change from baseline global level of volatile sulphur compounds (VSC) [ Time Frame: after 15' and after 3 weeks ]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
- Change from baseline microbial load of saliva [ Time Frame: after 3 weeks ]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).
- Change from baseline microbial load of tongue coating [ Time Frame: after 3 weeks ]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).
- Patients' opinion [ Time Frame: after 3 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747226
|Contact: Marc Quirynen, PhD, DDS||+32 16 33 24 firstname.lastname@example.org|
|Department of Periodontology, KULeuven|
|Leuven, Belgium, 3000|
|Contact: Jesica Dadamio, Master Bioch +32 16 347282 email@example.com|
|Sub-Investigator: Jesica Dadamio, Master Bioch|
|Sub-Investigator: Sophie De Geest, DDS|
|Principal Investigator: Marc Quirynen, PhD, DDS|
|Principal Investigator:||Marc Quirynen, PhD, DDS||Universitarie Ziekenhuis Leuven|