GingivitisNCT02894593
Alcohol-free Essential Oils Containing Mouthrinse Efficacy on 3-day Supragingival Plaque Regrowth
A study testing alcohol free essential oils mouthwash, alcohol essential oils mouthwash and 0.20% chlorhexidine mouthwash in people with Gingivitis and Periodontitis, run by University of L'Aquila at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the antiplaque effects of an alcohol-free essential-oil containing mouthrinse - Listerine Zero (LZ) and an alcohol-based essential oils (EO+) mouthwash compared to a positive control of 0.20% chlorhexidine (CHX) mouthwash, and a negative control of a placebo solution (saline)… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Periodontitis
- What is being tested?
- alcohol free essential oils mouthwash, alcohol essential oils mouthwash and 0.20% chlorhexidine mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Jul 2016
- 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
- dentition with ≥ 20 evaluable teeth (minimum of five teeth per quadrant)
- 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: Alcohol-free Essential Oils Containing Mouthrinse Efficacy on 3-day Supragingival Plaque Regrowth: a Randomized Crossover Clinical Trial
The purpose of this study is to evaluate the antiplaque effects of an alcohol-free essential-oil containing mouthrinse - Listerine Zero (LZ) and an alcohol-based essential oils (EO+) mouthwash compared to a positive control of 0.20% chlorhexidine (CHX) mouthwash, and a negative control of a placebo solution (saline), using an in vivo plaque regrowth model of 3 days.
Read the detailed description
Plaque is a biofilm of microorganisms responsible for the development of caries and periodontal disease. The daily removal of supragingival dental plaque represents a major factor in the prevention of caries, gingivitis and periodontitis. Plaque control is largely obtained by daily effective tooth brushing and inter-dental cleaning, but in some cases plaque removal can be improved by adding the use of a mouthwash.
An effective action of chemical formulation (especially antiseptics) to control plaque and gingivitis levels has been proved.
Most mouthwashes contain an alcohol (especially ethanol) in order to act as a carrier agent for active essential oils to penetrate the plaque, and to give the subject a "clean mouth sensation".
The alcohol content of mouthwashes, besides having antiseptic properties, serves the purpose of breaking down or dissolving active principles, in addition to that of preserving the formula components, although such content does not directly contribute to effective biofilm and gingivitis control.
However, there are some contraindications in the use of alcohol-based mouthwashes, like the use by infants, pregnant women, alcohol addicts and patients with mucosal injuries. There are also some undesirable effects, like burning or sore sensation, or a painful sensation for patients with existing soft tissue injuries, or a perception of dryness in the mouth.
In order to avoid the use of alcohol-based mouthwashes in particular conditions, scientific interest is becoming more widespread in introducing a mouthrinse with strong anti-plaque qualities and no alcoholic ingredients.
One of these product is the alcohol-free essential oil mouthwash Listerine Zero (LZ), that has little documentation with regard to its anti-plaque effects.
The aim of this study was to evaluate the antiplaque effects of an alcohol-free essential oil mouthwash (Listerine Zero, LZ) and a alcohol-based essential oil mouthwash (EO+), compared to a positive control of a 0.2% chlorhexidine mouthwash (CHX), and a negative control of a placebo solution (saline), using an in vivo plaque regrowth model of 3 days.
The study was designed as a double-masked, randomized, crossover clinical trial, involving 21 volunteers to compare four different mouthwashes, using a 3-day plaque regrowth model. After receiving thorough professional prophylaxis at baseline, over the next 3 days, each volunteer refrained from all oral hygiene measures and performed two daily rinses with 15 ml of the test mouthwashes. EO+ was compared to LZ. CHX rinse served as a positive control, and a placebo solution as a negative control. At the end of each experimental period, plaque index (PI) was assessed, and a panelists completed through a visual analogue scale (VAS) questionnaire evaluating the organoleptic properties of each product. Each subject underwent a 14-day washout period, and then there was another allocation.
- Conditions
- Gingivitis, Periodontitis
- Being tested
- alcohol free essential oils mouthwash, alcohol essential oils mouthwash, 0.20% chlorhexidine mouthwash, Placebo
- Keywords
- Antiplaque agents, chemical plaque control, oral hygiene, essential oils, alcohol, mouthwash
- Medical subject headings
- Gingivitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alcohol free essential oils mouthwashOther
Also called Listerine Zero, Johnson & Johnson Consumer Inc.
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
alcohol essential oils mouthwashOther
Also called Listerine, Johnson & Johnson Consumer Inc.
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
0.20% chlorhexidine mouthwashOther
Also called Meridol Chlorhexidine 0.20, GABA International AG
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
PlaceboOther
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
| Study group | Role | What they receive |
|---|---|---|
| alcohol essential oils mouthwash | Other | All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. Receives: Other: alcohol essential oils mouthwash |
| 0.20% chlorhexidine mouthwash | Active comparator | All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. Receives: Other: 0.20% chlorhexidine mouthwash |
| Placebo | Placebo comparator | All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. Receives: Other: Placebo |
| alcohol free essential oils mouthwash | Experimental | All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. Receives: Other: alcohol free essential oils mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental plaque regrowth by clinical plaque index
all of the volunteers were examined with an erythrosine solution, and the plaque in both groups was recorded at six sites per tooth using the Quigley and Hein index , as modified by Turesky et al. and further modified by Lobene et al.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionOct 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies 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
- 21 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
- NCT02894593
- Sponsor's protocol ID
- RCT_001_16
- Status last verified
- Dec 2016
- First submitted
- 4 Sep 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22171999Marchetti 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 26522915Paraskevas S, Rosema NA, Versteeg P, Van der Velden U, Van der Weijden GA. Chlorine dioxide and chlorhexidine mouthrinses compared in a 3-day plaque accumulation model. J Periodontol. 2008 Aug;79(8):1395-400. doi: 10.1902/jop.2008.070630.
PubMed 18672988Charles CA, Amini P, Gallob J, Shang H, McGuire JA, Costa R. Antiplaque and antigingivitis efficacy of an alcohol-free essential-oil containing mouthrinse: a 2-week clinical trial. Am J Dent. 2012 Aug;25(4):195-8.
PubMed 23082381Marchetti E, Tecco S, Caterini E, Casalena F, Quinzi V, Mattei A, Marzo G. Alcohol-free essential oils containing mouthrinse efficacy on three-day supragingival plaque regrowth: a randomized crossover clinical trial. Trials. 2017 Mar 31;18(1):154. doi: 10.1186/s13063-017-1901-z.
PubMed 28359280
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol-free Essential Oils Containing Mouthrinse Efficacy on 3-day Supragingival Plaque Regrowth: a Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT02894593
- Acronym / sponsor ID
- RCT_001_16
- Conditions
- Gingivitis, Periodontitis
- Keywords
- Antiplaque agents, chemical plaque control, oral hygiene, essential oils, alcohol, mouthwash
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
The purpose of this study is to evaluate the antiplaque effects of an alcohol-free essential-oil containing mouthrinse - Listerine Zero (LZ) and an alcohol-based essential oils (EO+) mouthwash compared to a positive control of 0.20% chlorhexidine (CHX) mouthwash, and a negative control of a placebo solution (saline), using an in vivo plaque regrowth model of 3 days.
Detailed description
Plaque is a biofilm of microorganisms responsible for the development of caries and periodontal disease. The daily removal of supragingival dental plaque represents a major factor in the prevention of caries, gingivitis and periodontitis. Plaque control is largely obtained by daily effective tooth brushing and inter-dental cleaning, but in some cases plaque removal can be improved by adding the use of a mouthwash.
An effective action of chemical formulation (especially antiseptics) to control plaque and gingivitis levels has been proved.
Most mouthwashes contain an alcohol (especially ethanol) in order to act as a carrier agent for active essential oils to penetrate the plaque, and to give the subject a "clean mouth sensation".
The alcohol content of mouthwashes, besides having antiseptic properties, serves the purpose of breaking down or dissolving active principles, in addition to that of preserving the formula components, although such content does not directly contribute to effective biofilm and gingivitis control.
However, there are some contraindications in the use of alcohol-based mouthwashes, like the use by infants, pregnant women, alcohol addicts and patients with mucosal injuries. There are also some undesirable effects, like burning or sore sensation, or a painful sensation for patients with existing soft tissue injuries, or a perception of dryness in the mouth.
In order to avoid the use of alcohol-based mouthwashes in particular conditions, scientific interest is becoming more widespread in introducing a mouthrinse with strong anti-plaque qualities and no alcoholic ingredients.
One of these product is the alcohol-free essential oil mouthwash Listerine Zero (LZ), that has little documentation with regard to its anti-plaque effects.
The aim of this study was to evaluate the antiplaque effects of an alcohol-free essential oil mouthwash (Listerine Zero, LZ) and a alcohol-based essential oil mouthwash (EO+), compared to a positive control of a 0.2% chlorhexidine mouthwash (CHX), and a negative control of a placebo solution (saline), using an in vivo plaque regrowth model of 3 days.
The study was designed as a double-masked, randomized, crossover clinical trial, involving 21 volunteers to compare four different mouthwashes, using a 3-day plaque regrowth model. After receiving thorough professional prophylaxis at baseline, over the next 3 days, each volunteer refrained from all oral hygiene measures and performed two daily rinses with 15 ml of the test mouthwashes. EO+ was compared to LZ. CHX rinse served as a positive control, and a placebo solution as a negative control. At the end of each experimental period, plaque index (PI) was assessed, and a panelists completed through a visual analogue scale (VAS) questionnaire evaluating the organoleptic properties of each product. Each subject underwent a 14-day washout period, and then there was another allocation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| alcohol essential oils mouthwash | Other | Other: alcohol essential oils mouthwashAll subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. |
| 0.20% chlorhexidine mouthwash | Active comparator | Other: 0.20% chlorhexidine mouthwashAll subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. |
| Placebo | Placebo comparator | Other: PlaceboAll subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. |
| alcohol free essential oils mouthwash | Experimental | Other: alcohol free essential oils mouthwashAll subjects were instructed to rinse twice a day, in the morning and in the evening, 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 (2 listed)
- dentition with ≥ 20 evaluable teeth (minimum of five teeth per quadrant)
- 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 |
|---|---|---|
| alcohol free essential oils mouthwashAlso: Listerine Zero, Johnson & Johnson Consumer Inc.All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. | Other | alcohol free essential oils mouthwash |
| alcohol essential oils mouthwashAlso: Listerine, Johnson & Johnson Consumer Inc.All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. | Other | alcohol essential oils mouthwash |
| 0.20% chlorhexidine mouthwashAlso: Meridol Chlorhexidine 0.20, GABA International AGAll subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. | Other | 0.20% chlorhexidine mouthwash |
| PlaceboAll subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed. | Other | Placebo |
Primary outcome
Dental plaque regrowth by clinical plaque index
Time frame: 3 days
all of the volunteers were examined with an erythrosine solution, and the plaque in both groups was recorded at six sites per tooth using the Quigley and Hein index , as modified by Turesky et al. and further modified by Lobene et al.
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 15 Dec 2016.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 18672988Paraskevas S, Rosema NA, Versteeg P, Van der Velden U, Van der Weijden GA. Chlorine dioxide and chlorhexidine mouthrinses compared in a 3-day plaque accumulation model. J Periodontol. 2008 Aug;79(8):1395-400. doi: 10.1902/jop.2008.070630.
- Results publication: PubMed 23082381Charles CA, Amini P, Gallob J, Shang H, McGuire JA, Costa R. Antiplaque and antigingivitis efficacy of an alcohol-free essential-oil containing mouthrinse: a 2-week clinical trial. Am J Dent. 2012 Aug;25(4):195-8.
- Derived from this study: PubMed 28359280Marchetti E, Tecco S, Caterini E, Casalena F, Quinzi V, Mattei A, Marzo G. Alcohol-free essential oils containing mouthrinse efficacy on three-day supragingival plaque regrowth: a randomized crossover clinical trial. Trials. 2017 Mar 31;18(1):154. doi: 10.1186/s13063-017-1901-z.
- 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 alcohol free essential oils mouthwash, alcohol essential oils mouthwash and 0.20% chlorhexidine mouthwash in people with Gingivitis and Periodontitis, 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 2 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 15 Dec 2016. 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?
Dental plaque regrowth by clinical plaque index (time frame: 3 days). 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 NCT02894593, which also lists 5 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 15 Dec 2016.