Oral BiofilmPhase 4NCT02267239
Methodology Antiseptic Application, Influence on Oral Biofilm.
A Phase 4 study testing essential oils, immersion, Chlorhexidine, immersion and essential oils, mouthwash in people with Oral Biofilm and Periodontitis, run by University of Santiago de Compostela at 1 site in Spain.
Trial summary
The study has the objective to compare two different methodology of application the antiseptic on the oral biofilm will be formed during 48h in situ on a specific device. The first one using the immersion in the antiseptic solution, as much of the authors did in the past. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Biofilm, Periodontitis, Gingivitis
- What is being tested?
- essential oils, immersion, Chlorhexidine, immersion and essential oils, mouthwash
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2014to Nov 2014
- Phase
- Phase 4
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good oral health status: a minimum of 24 permanent teeth with no evidence of gingivitis or periodontitis and absence of untreated caries
Who cannot join
- smoker or former smoker
- presence of dental prostheses or orthodontic devices
- antibiotic treatment or routine use of oral antiseptics in the previous three months
- presence of any systemic disease that could alter the production or composition of saliva
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15782
Inmaculada Tomás Carmona, Senior Lecture, +34647344494, inmaculada.tomas@usc.es
About this study
Official title: Methodology of Application and Immediate Effect of the Essential Oils and 0.2% Chlorhexidine on Oral Biofilm: Immersion Versus Mouthwash.
The study has the objective to compare two different methodology of application the antiseptic on the oral biofilm will be formed during 48h in situ on a specific device. The first one using the immersion in the antiseptic solution, as much of the authors did in the past. And the second way doing a active mouthwash, as the manufacturer recommends.
The study will compare two different antiseptic solutions, the chlorhexidine (0.2% Oraldine Perio) and the essential oils (Listerine Mentol) with the two different application and compared the bacterial vitality, thickness and covering grade between solutions and with a basal sample.
Read the detailed description
15 healthy volunteers, between 20 and 45 years old, will use during 48 hours two specific oral devices with 3 glass disks each. After this period, one of the disk will be drawn from the device and it will be immersed in Live/Dead BacLight solution for 15 minutes and then the disk will be analysed by the Confocal Laser Scanning Microscope (CLSM). Immediately, another disk will be removed from the intraoral device and immersed in the antiseptic solution, being analysed by the CLSM as well. After that, the volunteers will do the mouthwash with the antiseptic solution (as stated in the specific protocol) and the last disk will be drawn from the device and will be analysed by the CLSM following the same protocol. The other 3 disk will undergo the same protocol of baseline, immersion and mouthwash, but with the other antiseptic solution.
The CLSM data will be analysed and the bacterial vitality, thickness and covering grade will be calculated. Finally the statistical analysis will be applied (Pairwise comparisons, with the Bonferroni adjustment).
- Conditions
- Oral Biofilm, Periodontitis, Gingivitis
- Being tested
- essential oils, immersion, Chlorhexidine, immersion, essential oils, mouthwash, chlorhexidine, mouthwash, professional oral cleaning
- Keywords
- essential oils, chlorhexidine, microscopy, confocal, immersion, antiseptic
- Medical subject headings
- Periodontitis, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
essential oils, immersionDrug
Also called Listerine, Listerine Mentol, essential oil
A single, 30-second immersion in 1 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson \& Johnson, Madrid, Spain) (I-EO).
Chlorhexidine, immersionDrug
Also called Oraldine Perio
A single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2% CHX).
essential oils, mouthwashDrug
Also called Listerine, Listerine Mentol, essential oil
A single, 30-second mouthwash with 20 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson \& Johnson, Madrid, Spain) (M-EO).
chlorhexidine, mouthwashDrug
Also called Oraldine perio
A single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2% CHX).
professional oral cleaningProcedure or surgery
Also called tartrectomy, scaling and polishing
scaling and polishing teeth of the volunteers
Plaster castProcedure or surgery
Also called model, dental impresionss
Taking a plaster cast of the volunteers' mouth
IDODSDevice
Also called Intraoral Device of Overlaid Disk-holding Splints
Specific intraoral device which carries six glass disks
| Study group | Role | What they receive |
|---|---|---|
| Essential Oils, immersion | Active comparator | Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution Receives: Drug: essential oils, immersion; Procedure: professional oral cleaning; Procedure: Plaster cast; Device: IDODS |
| Chlorhexidine, immersion | Active comparator | Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution Receives: Drug: Chlorhexidine, immersion; Procedure: professional oral cleaning; Procedure: Plaster cast; Device: IDODS |
| baseline | Other | Professional oral cleaning Plaster cast IDODS Disk in basal conditions. Receives: Procedure: professional oral cleaning; Procedure: Plaster cast; Device: IDODS |
| Essential Oils, mouthwash | Active comparator | Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution Receives: Drug: essential oils, mouthwash; Procedure: professional oral cleaning; Procedure: Plaster cast; Device: IDODS |
| Chlorhexidine, mouthwash | Active comparator | Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution Receives: Drug: chlorhexidine, mouthwash; Procedure: professional oral cleaning; Procedure: Plaster cast; Device: IDODS |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in bacterial vitality
percentage of live bacteria in the sample
Measured: baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
change in thickness
maximum numbers of layers (1micra per layer) with continuous presence of bacteria
Measured: baseline, 30 seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
change in covering grade
percentage of the disk surface occupied by the biofilm
Measured: baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral BiofilmStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santiago de Compostela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inmaculada Tomas, University of Santiago de Compostela
- Investigators
- Inmaculada Inmaculada, Senior lecturer, Study director, Faculty of Medicine and Dentistry of the University of Santiago de Compostela Santiago de Compostela, A Coruña, Spain, 15782
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267239
- Sponsor's protocol ID
- immersion vs. mouthwash
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Prada-Lopez I, Quintas V, Casares-De-Cal MA, Suarez-Quintanilla JA, Suarez-Quintanilla D, Tomas I. Ex vivo vs. in vivo antibacterial activity of two antiseptics on oral biofilm. Front Microbiol. 2015 Jul 2;6:655. doi: 10.3389/fmicb.2015.00655. eCollection 2015.
PubMed 26191050
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methodology of Application and Immediate Effect of the Essential Oils and 0.2% Chlorhexidine on Oral Biofilm: Immersion Versus Mouthwash.
- ClinicalTrials.gov ID
- NCT02267239
- Acronym / sponsor ID
- immersion vs. mouthwash
- Conditions
- Oral Biofilm, Periodontitis, Gingivitis
- Keywords
- essential oils, chlorhexidine, microscopy, confocal, immersion, antiseptic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Santiago de CompostelaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (estimated)
- First posted
- 17 Oct 2014 (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 study has the objective to compare two different methodology of application the antiseptic on the oral biofilm will be formed during 48h in situ on a specific device. The first one using the immersion in the antiseptic solution, as much of the authors did in the past. And the second way doing a active mouthwash, as the manufacturer recommends.
The study will compare two different antiseptic solutions, the chlorhexidine (0.2% Oraldine Perio) and the essential oils (Listerine Mentol) with the two different application and compared the bacterial vitality, thickness and covering grade between solutions and with a basal sample.
Detailed description
15 healthy volunteers, between 20 and 45 years old, will use during 48 hours two specific oral devices with 3 glass disks each. After this period, one of the disk will be drawn from the device and it will be immersed in Live/Dead BacLight solution for 15 minutes and then the disk will be analysed by the Confocal Laser Scanning Microscope (CLSM). Immediately, another disk will be removed from the intraoral device and immersed in the antiseptic solution, being analysed by the CLSM as well. After that, the volunteers will do the mouthwash with the antiseptic solution (as stated in the specific protocol) and the last disk will be drawn from the device and will be analysed by the CLSM following the same protocol. The other 3 disk will undergo the same protocol of baseline, immersion and mouthwash, but with the other antiseptic solution.
The CLSM data will be analysed and the bacterial vitality, thickness and covering grade will be calculated. Finally the statistical analysis will be applied (Pairwise comparisons, with the Bonferroni adjustment).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Essential Oils, immersion | Active comparator | Drug: essential oils, immersion, Procedure: professional oral cleaning, Procedure: Plaster cast, Device: IDODSProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution |
| Chlorhexidine, immersion | Active comparator | Drug: Chlorhexidine, immersion, Procedure: professional oral cleaning, Procedure: Plaster cast, Device: IDODSProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution |
| baseline | Other | Procedure: professional oral cleaning, Procedure: Plaster cast, Device: IDODSProfessional oral cleaning Plaster cast IDODS Disk in basal conditions. |
| Essential Oils, mouthwash | Active comparator | Drug: essential oils, mouthwash, Procedure: professional oral cleaning, Procedure: Plaster cast, Device: IDODSProfessional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution |
| Chlorhexidine, mouthwash | Active comparator | Drug: chlorhexidine, mouthwash, Procedure: professional oral cleaning, Procedure: Plaster cast, Device: IDODSProfessional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- good oral health status: a minimum of 24 permanent teeth with no evidence of gingivitis or periodontitis and absence of untreated caries
Key exclusion criteria (4 listed)
- smoker or former smoker
- presence of dental prostheses or orthodontic devices
- antibiotic treatment or routine use of oral antiseptics in the previous three months
- presence of any systemic disease that could alter the production or composition of saliva
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 |
|---|---|---|
| essential oils, immersionAlso: Listerine, Listerine Mentol, essential oilA single, 30-second immersion in 1 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson \& Johnson, Madrid, Spain) (I-EO). | Drug | Essential Oils, immersion |
| Chlorhexidine, immersionAlso: Oraldine PerioA single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2% CHX). | Drug | Chlorhexidine, immersion |
| essential oils, mouthwashAlso: Listerine, Listerine Mentol, essential oilA single, 30-second mouthwash with 20 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson \& Johnson, Madrid, Spain) (M-EO). | Drug | Essential Oils, mouthwash |
| chlorhexidine, mouthwashAlso: Oraldine perioA single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2% CHX). | Drug | Chlorhexidine, mouthwash |
| professional oral cleaningAlso: tartrectomy, scaling and polishingscaling and polishing teeth of the volunteers | Procedure or surgery | Chlorhexidine, immersion, Chlorhexidine, mouthwash, Essential Oils, immersion, Essential Oils, mouthwash, baseline |
| Plaster castAlso: model, dental impresionssTaking a plaster cast of the volunteers' mouth | Procedure or surgery | Chlorhexidine, immersion, Chlorhexidine, mouthwash, Essential Oils, immersion, Essential Oils, mouthwash, baseline |
| IDODSAlso: Intraoral Device of Overlaid Disk-holding SplintsSpecific intraoral device which carries six glass disks | Device | Chlorhexidine, immersion, Chlorhexidine, mouthwash, Essential Oils, immersion, Essential Oils, mouthwash, baseline |
Primary outcome
change in bacterial vitality
Time frame: baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
percentage of live bacteria in the sample
change in thickness
Time frame: baseline, 30 seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
maximum numbers of layers (1micra per layer) with continuous presence of bacteria
change in covering grade
Time frame: baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
percentage of the disk surface occupied by the biofilm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
- Derived from this study: PubMed 26191050Prada-Lopez I, Quintas V, Casares-De-Cal MA, Suarez-Quintanilla JA, Suarez-Quintanilla D, Tomas I. Ex vivo vs. in vivo antibacterial activity of two antiseptics on oral biofilm. Front Microbiol. 2015 Jul 2;6:655. doi: 10.3389/fmicb.2015.00655. eCollection 2015.
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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.
Inmaculada Inmaculada, Senior lecturer study director
Faculty of Medicine and Dentistry of the University of Santiago de Compostela Santiago de Compostela, A Coruña, Spain, 15782
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing essential oils, immersion, Chlorhexidine, immersion and essential oils, mouthwash in people with Oral Biofilm and Periodontitis, run by University of Santiago de Compostela at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 23 Oct 2014. 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 Spain. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inmaculada Tomás Carmona, Senior lecturer (+34647344494, inmaculada.tomas@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in bacterial vitality (time frame: baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)). The study lists 3 primary outcomes in all. 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 NCT02267239, which also lists 1 linked publication.
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 23 Oct 2014.