Methodology Antiseptic Application, Influence on Oral Biofilm.

October 22, 2014 updated by: Inmaculada Tomas, University of Santiago de Compostela

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

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

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15782
        • Recruiting
        • University of Santiago de Compostela
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Listerine, Listerine Mentol, essential oil
scaling and polishing teeth of the volunteers
Other Names:
  • tartrectomy, scaling and polishing
Taking a plaster cast of the volunteers' mouth
Other Names:
  • model, dental impresionss
Specific intraoral device which carries six glass disks
Other Names:
  • Intraoral Device of Overlaid Disk-holding Splints
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:
  • tartrectomy, scaling and polishing
Taking a plaster cast of the volunteers' mouth
Other Names:
  • model, dental impresionss
Specific intraoral device which carries six glass disks
Other Names:
  • Intraoral Device of Overlaid Disk-holding Splints
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:
  • Oraldine Perio
Other: baseline
Professional oral cleaning Plaster cast IDODS Disk in basal conditions.
scaling and polishing teeth of the volunteers
Other Names:
  • tartrectomy, scaling and polishing
Taking a plaster cast of the volunteers' mouth
Other Names:
  • model, dental impresionss
Specific intraoral device which carries six glass disks
Other Names:
  • Intraoral Device of Overlaid Disk-holding Splints
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:
  • tartrectomy, scaling and polishing
Taking a plaster cast of the volunteers' mouth
Other Names:
  • model, dental impresionss
Specific intraoral device which carries six glass disks
Other Names:
  • Intraoral Device of Overlaid Disk-holding Splints
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:
  • Listerine, Listerine Mentol, essential oil
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:
  • tartrectomy, scaling and polishing
Taking a plaster cast of the volunteers' mouth
Other Names:
  • model, dental impresionss
Specific intraoral device which carries six glass disks
Other Names:
  • Intraoral Device of Overlaid Disk-holding Splints
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:
  • Oraldine perio

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

November 1, 2014

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 14, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Estimate)

October 23, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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