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Effect of Single Rinsing With Three Different Types of Mouthwash on VSC Levels in Morning Breath

Primary Purpose

Halitosis

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
0.05%chlorhexidine mouthwash
0.05% sodium fluoride mouthwash
alcohol free essential oils mouthwash
Placebo
Sponsored by
University of L'Aquila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Halitosis focused on measuring Morning bad breath, Halitosis, OralChroma, mouthwash

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • age between 20 and 50 years old

Exclusion Criteria:

  • 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

Sites / Locations

  • University of L'Aquila, Division of Periodontology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

0.05%chlorhexidine mouthwash

0.05% sodium fluoride mouthwash

alcohol free essential oils mouthwash

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 18, 2020
Last Updated
February 19, 2020
Sponsor
University of L'Aquila
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1. Study Identification

Unique Protocol Identification Number
NCT04279106
Brief Title
Effect of Single Rinsing With Three Different Types of Mouthwash on VSC Levels in Morning Breath
Official Title
"Effect of Single Rinsing With Three Different Types of Mouthwash on VSC Levels in Morning Breath; Randomized Clinical Trial, Double-blind Cross-sectional Study"
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
January 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of L'Aquila

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study was designed as a double-masked, four-group, randomized, crossover clinical trial. The volunteers were randomly assigned. Randomization was performed using computer generated random numbers. The allocation of active or control solutions was undertaken by a person not directly involved in the research project. No changes to methods after trial commencement (such as eligibility criteria) were performed. Participants Thirty-six nondental student volunteers (17 women and 15 men; age range 34-22 years old; mean age 27,7) participated in the study. The subjects were recruited through advertisements. All of the candidates were screened for suitability by the research team. The selection criteria were: Good general health condition, dentition with ≥20 evaluable teeth (minimum of five teeth per quadrant), no oral lesions, no severe periodontal problems (no probing depth ≥5 mm or attachment loss >2 mm), and no removable prostheses or orthodontic bands or appliances. Persons allergic to several mouthwash components were excluded from the study. All eligible volunteers were given oral and written information about the products and the purpose of the study and were asked to sign an informed consent form. The study was conducted from 3 September 2018 to 10 December 2019 in the Division of Periodontology, University of L'Aquila. During the first information meeting, at each participant was given the mouthwash samples to be tested and a sealed envelope in which the sequence to follow was specified. The sequence also included the use of a placebo. The subjects were asked not to change their eating habits, but to refrain from taking halogen substances on the evenings prior the evaluations. About 12 hours before the analysis, the participants, refraining from oral hygiene practices, performed a 30-second rinse, followed by a gargle. They also committed themselves not to take food or drinks, not to brush their teeth, not to smoke and not to use cosmetics (their fragrances could have disturbed the operator's perception of odours), between this practice and the evaluation. The following morning the values of hydrogen sulphide, methyl mercaptan and dimethyl sulphide were measured and the values of the Rosenberg scale (0. Absence of odor;1. Barely perceptible odor;2. Slight but clearly perceptible odor;3. Moderate odour; 4. Very annoying smell; 5. Extremely bad smell) and the Winkel index (0. Absence of patina;1. Slight presence of patina; 2. Considerable presence of patina) were assigned. The assessment of morning halitosis was carried out through organoleptic measurement with a lingual patina supervision and with the aid of a dedicated device, the Oral Chroma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
Keywords
Morning bad breath, Halitosis, OralChroma, mouthwash

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.05%chlorhexidine mouthwash
Arm Type
Experimental
Arm Description
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.
Arm Title
0.05% sodium fluoride mouthwash
Arm Type
Active Comparator
Arm Description
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.
Arm Title
alcohol free essential oils mouthwash
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
0.05%chlorhexidine mouthwash
Other Intervention Name(s)
Mentadent professional 0.05%chlorhexidine. MIROMED Srl
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
0.05% sodium fluoride mouthwash
Other Intervention Name(s)
CB12®.Mylan N.V.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
alcohol free essential oils mouthwash
Other Intervention Name(s)
Listerine, Johnson & Johnson Consumer Inc.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of VSCs
Description
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
Time Frame
1Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age between 20 and 50 years old Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Marzo, DMD
Organizational Affiliation
University of L'Aquila
Official's Role
Study Chair
Facility Information:
Facility Name
University of L'Aquila, Division of Periodontology
City
L'aquila
State/Province
AQ
ZIP/Postal Code
67100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26522915
Citation
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.
Results Reference
background
PubMed Identifier
22171999
Citation
Marchetti 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.
Results Reference
background
PubMed Identifier
25727335
Citation
Mendes 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.
Results Reference
background
PubMed Identifier
11577950
Citation
van 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.
Results Reference
background

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Effect of Single Rinsing With Three Different Types of Mouthwash on VSC Levels in Morning Breath

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