- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02267239
Methodology Antiseptic Application, Influence on Oral Biofilm.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Inmaculada Tomás Carmona, Senior lecturer
- Phone Number: +34647344494
- Email: inmaculada.tomas@usc.es
Study Locations
-
-
A Coruña
-
Santiago de Compostela, A Coruña, Spain, 15782
- Recruiting
- University of Santiago de Compostela
-
Contact:
- Inmaculada Tomás Carmona, Senior Lecture
- Phone Number: +34647344494
- Email: inmaculada.tomas@usc.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- good oral health status: a minimum of 24 permanent teeth with no evidence of gingivitis or periodontitis and absence of untreated caries
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Essential Oils, immersion
Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution
|
A single, 30-second immersion in 1 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (I-EO).
Other Names:
scaling and polishing teeth of the volunteers
Other Names:
Taking a plaster cast of the volunteers' mouth
Other Names:
Specific intraoral device which carries six glass disks
Other Names:
|
Active Comparator: Chlorhexidine, immersion
Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution
|
scaling and polishing teeth of the volunteers
Other Names:
Taking a plaster cast of the volunteers' mouth
Other Names:
Specific intraoral device which carries six glass disks
Other Names:
A single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2%
CHX).
Other Names:
|
Other: baseline
Professional oral cleaning Plaster cast IDODS Disk in basal conditions.
|
scaling and polishing teeth of the volunteers
Other Names:
Taking a plaster cast of the volunteers' mouth
Other Names:
Specific intraoral device which carries six glass disks
Other Names:
|
Active Comparator: Essential Oils, mouthwash
Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution
|
scaling and polishing teeth of the volunteers
Other Names:
Taking a plaster cast of the volunteers' mouth
Other Names:
Specific intraoral device which carries six glass disks
Other Names:
A single, 30-second mouthwash with 20 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (M-EO).
Other Names:
|
Active Comparator: Chlorhexidine, mouthwash
Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution
|
scaling and polishing teeth of the volunteers
Other Names:
Taking a plaster cast of the volunteers' mouth
Other Names:
Specific intraoral device which carries six glass disks
Other Names:
A single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2%
CHX).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
|
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
|
baseline, 30 seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
|
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
|
baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
|
Collaborators and Investigators
Investigators
- Study Director: Inmaculada Inmaculada, Senior lecturer, Faculty of Medicine and Dentistry of the University of Santiago de Compostela Santiago de Compostela, A Coruña, Spain, 15782
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Gingival Diseases
- Periodontitis
- Gingivitis
- Physiological Effects of Drugs
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Protective Agents
- Dermatologic Agents
- Antifungal Agents
- Antipruritics
- Cariostatic Agents
- Disinfectants
- Listerine
- Sodium Fluoride
- Chlorhexidine
- Chlorhexidine gluconate
- Hexetidine
- Menthol
Other Study ID Numbers
- immersion vs. mouthwash
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Periodontitis
-
Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraCompletedPeriodontitis, Aggressive | Periodontitis, AdultItaly
-
Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyUnknownGeneralized Adult Periodontitis
-
Asem Mohammed Kamel AliCompletedMolar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) | Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)Egypt
-
Columbia UniversityCompletedPeriodontal Diseases | Generalized Moderate Chronic Periodontitis | Generalized Severe Chronic PeriodontitisUnited States
-
Aga Khan UniversityCompletedChronic Apical PeriodontitisPakistan
-
Postgraduate Institute of Dental Sciences RohtakUnknownChronic Apical PeriodontitisIndia
-
University Hospital, Strasbourg, FranceRecruitingPeriodontitis, AdultFrance
-
October University for Modern Sciences and ArtsCompletedPeriodontitis, AdultEgypt
-
Loma Linda UniversityTerminated
-
PiLeJeCompletedProbiotics, PeriodontitisFrance
Clinical Trials on essential oils, immersion
-
Etablissement Public de Santé Barthélemy DurandRecruitingPsychiatric Disorder | Benzodiazepine WithdrawalFrance
-
University of California, IrvineProcter and GambleTerminated
-
Ditte Gertz MogensenRecruiting
-
Center Eugene MarquisTerminated
-
Özlem ÇağanCompletedAnxiety | Aromatherapy | Pain, LaborTurkey
-
University of AlbertaTaiga BioActives Inc.WithdrawnUrinary Tract InfectionsCanada
-
Clinica Luganese MoncuccoCompletedBPSD (Behavioral and Psycological Symptoms of Dementia)Switzerland
-
Centre Francois BaclesseCompletedNausea and Vomiting | Aromatherapy | Essential Oil | Suportive CareFrance
-
Show Chwan Memorial HospitalRecruitingPain | Anxiety | Heart Rate VariabilityTaiwan