HalitosisNCT04279106
Effect of Single Rinsing With Three Different Types of Mouthwash on VSC Levels in Morning Breath
A study testing 0.05%chlorhexidine mouthwash, 0.05% sodium fluoride mouthwash and alcohol free essential oils mouthwash in people with Halitosis, run by University of L'Aquila at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Halitosis
- What is being tested?
- 0.05%chlorhexidine mouthwash, 0.05% sodium fluoride mouthwash and alcohol free essential oils mouthwash
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 3 Sep 2018to 16 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 20 and 50 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of L'Aquila, Division of Periodontology
L’Aquila, AQ, 67100
About this study
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"
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.
Read the 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.
- Conditions
- Halitosis
- Being tested
- 0.05%chlorhexidine mouthwash, 0.05% sodium fluoride mouthwash, alcohol free essential oils mouthwash, Placebo
- Keywords
- Morning bad breath, Halitosis, OralChroma, mouthwash
- Medical subject headings
- Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05%chlorhexidine mouthwashProcedure or surgery
Also called Mentadent professional 0.05%chlorhexidine. MIROMED Srl
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.
0.05% sodium fluoride mouthwashProcedure or surgery
Also called CB12®.Mylan N.V.
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.
alcohol free essential oils mouthwashProcedure or surgery
Also called Listerine, Johnson & Johnson Consumer Inc.
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.
PlaceboProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 0.05%chlorhexidine mouthwash | Experimental | 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. Receives: Procedure: 0.05%chlorhexidine mouthwash |
| 0.05% sodium fluoride mouthwash | Active comparator | 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. Receives: Procedure: 0.05% sodium fluoride mouthwash |
| alcohol free essential oils mouthwash | Active comparator | 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. Receives: Procedure: alcohol free essential oils mouthwash |
| Placebo | Placebo comparator | 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. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start3 Sep 2018
- Primary completion10 Dec 2019
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HalitosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Marchetti, University of L'Aquila
- Investigators
- Giuseppe Marzo, DMD, Study chair, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279106
- Sponsor's protocol ID
- RCT-01-2020
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26522915Marchetti 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.
PubMed 22171999Mendes 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.
PubMed 25727335van 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.
PubMed 11577950
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04279106
- Acronym / sponsor ID
- RCT-01-2020
- Conditions
- Halitosis
- Keywords
- Morning bad breath, Halitosis, OralChroma, mouthwash
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.05%chlorhexidine mouthwash | Experimental | Procedure: 0.05%chlorhexidine mouthwashAll 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 comparator | Procedure: 0.05% sodium fluoride mouthwashAll 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 comparator | Procedure: alcohol free essential oils mouthwashAll 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 comparator | Procedure: PlaceboAll 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age between 20 and 50 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.05%chlorhexidine mouthwashAlso: Mentadent professional 0.05%chlorhexidine. MIROMED SrlAll 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 or surgery | 0.05%chlorhexidine mouthwash |
| 0.05% sodium fluoride mouthwashAlso: CB12®.Mylan N.V.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 or surgery | 0.05% sodium fluoride mouthwash |
| alcohol free essential oils mouthwashAlso: Listerine, Johnson & Johnson Consumer Inc.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 or surgery | alcohol free essential oils mouthwash |
| PlaceboAll 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 or surgery | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 26522915Marchetti 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.
- Background: PubMed 22171999Marchetti 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.
- Background: PubMed 25727335Mendes 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.
- Background: PubMed 11577950van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Marzo, DMD study chair
University of L'Aquila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.05%chlorhexidine mouthwash, 0.05% sodium fluoride mouthwash and alcohol free essential oils mouthwash in people with Halitosis, run by University of L'Aquila at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of VSCs (time frame: 1Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279106, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.