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

Sponsor

University of L'Aquila (Other)

Overall Status

Completed

CT.gov ID

NCT04279106

Collaborator

(none)

Enrollment

Location

Arms

16.4

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Halitosis	Procedure: 0.05%chlorhexidine mouthwash Procedure: 0.05% sodium fluoride mouthwash Procedure: alcohol free essential oils mouthwash Procedure: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

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"

Actual Study Start Date :

Sep 3, 2018

Actual Primary Completion Date :

Dec 10, 2019

Actual Study Completion Date :

Jan 16, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Level of VSCs [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