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Methodology Antiseptic Application, Influence on Oral Biofilm.

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ClinicalTrials.gov Identifier: NCT02267239
Recruitment Status : Unknown
Verified October 2014 by Inmaculada Tomas, University of Santiago de Compostela.
Recruitment status was:  Recruiting
First Posted : October 17, 2014
Last Update Posted : October 23, 2014
Sponsor:
Information provided by (Responsible Party):
Inmaculada Tomas, University of Santiago de Compostela

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Oral Biofilm Periodontitis Gingivitis Drug: essential oils, immersion Drug: Chlorhexidine, immersion Drug: essential oils, mouthwash Drug: chlorhexidine, mouthwash Procedure: professional oral cleaning Procedure: Plaster cast Device: IDODS Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Methodology of Application and Immediate Effect of the Essential Oils and 0.2% Chlorhexidine on Oral Biofilm: Immersion Versus Mouthwash.
Study Start Date : October 2014
Estimated Primary Completion Date : November 2014

Resource links provided by the National Library of Medicine


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
Drug: essential oils, immersion
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 Name: Listerine, Listerine Mentol, essential oil

Procedure: professional oral cleaning
scaling and polishing teeth of the volunteers
Other Name: tartrectomy, scaling and polishing

Procedure: Plaster cast
Taking a plaster cast of the volunteers' mouth
Other Name: model, dental impresionss

Device: IDODS
Specific intraoral device which carries six glass disks
Other Name: 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
Drug: Chlorhexidine, immersion
A single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2% CHX).
Other Name: Oraldine Perio

Procedure: professional oral cleaning
scaling and polishing teeth of the volunteers
Other Name: tartrectomy, scaling and polishing

Procedure: Plaster cast
Taking a plaster cast of the volunteers' mouth
Other Name: model, dental impresionss

Device: IDODS
Specific intraoral device which carries six glass disks
Other Name: Intraoral Device of Overlaid Disk-holding Splints

baseline
Professional oral cleaning Plaster cast IDODS Disk in basal conditions.
Procedure: professional oral cleaning
scaling and polishing teeth of the volunteers
Other Name: tartrectomy, scaling and polishing

Procedure: Plaster cast
Taking a plaster cast of the volunteers' mouth
Other Name: model, dental impresionss

Device: IDODS
Specific intraoral device which carries six glass disks
Other Name: 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
Drug: essential oils, mouthwash
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 Name: Listerine, Listerine Mentol, essential oil

Procedure: professional oral cleaning
scaling and polishing teeth of the volunteers
Other Name: tartrectomy, scaling and polishing

Procedure: Plaster cast
Taking a plaster cast of the volunteers' mouth
Other Name: model, dental impresionss

Device: IDODS
Specific intraoral device which carries six glass disks
Other Name: Intraoral Device of Overlaid Disk-holding Splints

Active Comparator: Chlorhexidine, mouthwash
Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution
Drug: chlorhexidine, mouthwash
A single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2% CHX).
Other Name: Oraldine perio

Procedure: professional oral cleaning
scaling and polishing teeth of the volunteers
Other Name: tartrectomy, scaling and polishing

Procedure: Plaster cast
Taking a plaster cast of the volunteers' mouth
Other Name: model, dental impresionss

Device: IDODS
Specific intraoral device which carries six glass disks
Other Name: Intraoral Device of Overlaid Disk-holding Splints




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267239


Contacts
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Contact: Inmaculada Tomás Carmona, Senior lecturer +34647344494 inmaculada.tomas@usc.es

Locations
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Spain
University of Santiago de Compostela Recruiting
Santiago de Compostela, A Coruña, Spain, 15782
Contact: Inmaculada Tomás Carmona, Senior Lecture    +34647344494    inmaculada.tomas@usc.es   
Sponsors and Collaborators
University of Santiago de Compostela
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Inmaculada Tomas, Senior lecturer, University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT02267239     History of Changes
Other Study ID Numbers: immersion vs. mouthwash
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: October 2014
Keywords provided by Inmaculada Tomas, University of Santiago de Compostela:
essential oils
chlorhexidine
microscopy, confocal
immersion
antiseptic
Additional relevant MeSH terms:
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Periodontitis
Gingivitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Listerine
Hexetidine
Pharmaceutical Solutions
Sodium Fluoride
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Antifungal Agents