Effect of Single Rinsing With Three Different Types of Mouthwash on VSC Levels in Morning Breath
"Effect of Single Rinsing With Three Different Types of Mouthwash on VSC Levels in Morning Breath; Randomized Clinical Trial, Double-blind Cross-sectional Study"
1 other identifier
interventional
36
1 country
1
Brief Summary
Morning bad breath (MBB) is often an enduring upset; this double blind, crossover, randomized study aimed to evaluate the bad breath-suppressing of 3 commercially available mouth rinses (Mentadent Professional® 0.05%chlorhexidine (MPc), Meridol® Halitosis (MH) and CB12®) and a placebo on morning halitosis during a washout period of 1 week.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2020
CompletedFirst Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedFebruary 20, 2020
February 1, 2020
1.3 years
February 18, 2020
February 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Level of VSCs
The detection of halitosis with gas chromatography, which allows to obtain the exact values of VSCs present in the exhaled air, was performed trough the OralChroma. For the practical test, patients were asked to breathe through the nose for a couple of minutes, after inserting a 10 ml disposable syringe deprived of the needle in the oral cavity
1Day
Study Arms (4)
0.05%chlorhexidine mouthwash
EXPERIMENTALAll subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
0.05% sodium fluoride mouthwash
ACTIVE COMPARATORAll subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
alcohol free essential oils mouthwash
ACTIVE COMPARATORAll subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Placebo
PLACEBO COMPARATORAll subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Interventions
All subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
All subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
All subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
All subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Eligibility Criteria
You may qualify if:
- age between 20 and 50 years old
You may not qualify if:
- oral lesions
- severe periodontal problems (probing depth ≥5 mm or attachment loss \>2 mm)
- removable prostheses or orthodontic bands/ or appliances
- Subjects allergic to several mouthrinse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of L'Aquila, Division of Periodontology
L’Aquila, AQ, 67100, Italy
Related Publications (4)
Marchetti E, Casalena F, Capestro A, Tecco S, Mattei A, Marzo G. Efficacy of two mouthwashes on 3-day supragingival plaque regrowth: a randomized crossover clinical trial. Int J Dent Hyg. 2017 Feb;15(1):73-80. doi: 10.1111/idh.12185. Epub 2015 Nov 2.
PMID: 26522915BACKGROUNDMarchetti E, Mummolo S, Di Mattia J, Casalena F, Di Martino S, Mattei A, Marzo G. Efficacy of essential oil mouthwash with and without alcohol: a 3-day plaque accumulation model. Trials. 2011 Dec 15;12:262. doi: 10.1186/1745-6215-12-262.
PMID: 22171999BACKGROUNDMendes L, Coimbra J, Pereira AL, Resende M, Pinto MG. Comparative effect of a new mouthrinse containing chlorhexidine, triclosan and zinc on volatile sulphur compounds: a randomized, crossover, double-blind study. Int J Dent Hyg. 2016 Aug;14(3):202-8. doi: 10.1111/idh.12132. Epub 2015 Feb 26.
PMID: 25727335BACKGROUNDvan Steenberghe D, Avontroodt P, Peeters W, Pauwels M, Coucke W, Lijnen A, Quirynen M. Effect of different mouthrinses on morning breath. J Periodontol. 2001 Sep;72(9):1183-91. doi: 10.1902/jop.2000.72.9.1183.
PMID: 11577950BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giuseppe Marzo, DMD
University of L'Aquila
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Professor
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 20, 2020
Study Start
September 3, 2018
Primary Completion
December 10, 2019
Study Completion
January 16, 2020
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share