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

February 19, 2020 updated by: Enrico Marchetti, University of L'Aquila

"Effect of Single Rinsing With Three Different Types of Mouthwash on VSC Levels in Morning Breath; Randomized Clinical Trial, Double-blind Cross-sectional Study"

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AQ
      • L'aquila, AQ, Italy, 67100
        • University of L'Aquila, division of periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.05%chlorhexidine mouthwash
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.
Procedure: 0.05%chlorhexidine mouthwash
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.
Other Names:
  • Mentadent professional 0.05%chlorhexidine. MIROMED Srl
Active Comparator: 0.05% sodium fluoride mouthwash
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.
Procedure: 0.05% sodium fluoride mouthwash
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.
Other Names:
  • CB12®.Mylan N.V.
Active Comparator: alcohol free essential oils mouthwash
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.
Procedure: alcohol free essential oils mouthwash
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.
Other Names:
  • Listerine, Johnson & Johnson Consumer Inc.
Placebo Comparator: Placebo
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.
Procedure: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of VSCs
Time Frame: 1Day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Investigators

  • Study Chair: GIUSEPPE MARZO, DMD, University of L'Aquila

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2018

Primary Completion (Actual)

December 10, 2019

Study Completion (Actual)

January 16, 2020

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT-01-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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