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Methodology Antiseptic Application, Influence on Oral Biofilm.

Primary Purpose

Oral Biofilm, Periodontitis, Gingivitis

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
essential oils, immersion
Chlorhexidine, immersion
essential oils, mouthwash
chlorhexidine, mouthwash
professional oral cleaning
Plaster cast
IDODS
Sponsored by
University of Santiago de Compostela
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oral Biofilm focused on measuring essential oils, chlorhexidine, microscopy, confocal, immersion, antiseptic

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Santiago de CompostelaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Other

Active Comparator

Active Comparator

Arm Label

Essential Oils, immersion

Chlorhexidine, immersion

baseline

Essential Oils, mouthwash

Chlorhexidine, mouthwash

Arm Description

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution

Professional oral cleaning Plaster cast IDODS Disk in basal conditions.

Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution

Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution

Outcomes

Primary Outcome Measures

change in bacterial vitality
percentage of live bacteria in the sample
change in thickness
maximum numbers of layers (1micra per layer) with continuous presence of bacteria
change in covering grade
percentage of the disk surface occupied by the biofilm

Secondary Outcome Measures

Full Information

First Posted
October 8, 2014
Last Updated
October 22, 2014
Sponsor
University of Santiago de Compostela
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1. Study Identification

Unique Protocol Identification Number
NCT02267239
Brief Title
Methodology Antiseptic Application, Influence on Oral Biofilm.
Official Title
Methodology of Application and Immediate Effect of the Essential Oils and 0.2% Chlorhexidine on Oral Biofilm: Immersion Versus Mouthwash.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Biofilm, Periodontitis, Gingivitis
Keywords
essential oils, chlorhexidine, microscopy, confocal, immersion, antiseptic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Essential Oils, immersion
Arm Type
Active Comparator
Arm Description
Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution
Arm Title
Chlorhexidine, immersion
Arm Type
Active Comparator
Arm Description
Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution
Arm Title
baseline
Arm Type
Other
Arm Description
Professional oral cleaning Plaster cast IDODS Disk in basal conditions.
Arm Title
Essential Oils, mouthwash
Arm Type
Active Comparator
Arm Description
Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution
Arm Title
Chlorhexidine, mouthwash
Arm Type
Active Comparator
Arm Description
Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution
Intervention Type
Drug
Intervention Name(s)
essential oils, immersion
Other Intervention Name(s)
Listerine, Listerine Mentol, essential oil
Intervention Description
A single, 30-second immersion in 1 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (I-EO).
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine, immersion
Other Intervention Name(s)
Oraldine Perio
Intervention Description
A single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2% CHX).
Intervention Type
Drug
Intervention Name(s)
essential oils, mouthwash
Other Intervention Name(s)
Listerine, Listerine Mentol, essential oil
Intervention Description
A single, 30-second mouthwash with 20 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (M-EO).
Intervention Type
Drug
Intervention Name(s)
chlorhexidine, mouthwash
Other Intervention Name(s)
Oraldine perio
Intervention Description
A single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2% CHX).
Intervention Type
Procedure
Intervention Name(s)
professional oral cleaning
Other Intervention Name(s)
tartrectomy, scaling and polishing
Intervention Description
scaling and polishing teeth of the volunteers
Intervention Type
Procedure
Intervention Name(s)
Plaster cast
Other Intervention Name(s)
model, dental impresionss
Intervention Description
Taking a plaster cast of the volunteers' mouth
Intervention Type
Device
Intervention Name(s)
IDODS
Other Intervention Name(s)
Intraoral Device of Overlaid Disk-holding Splints
Intervention Description
Specific intraoral device which carries six glass disks
Primary Outcome Measure Information:
Title
change in bacterial vitality
Description
percentage of live bacteria in the sample
Time Frame
baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
Title
change in thickness
Description
maximum numbers of layers (1micra per layer) with continuous presence of bacteria
Time Frame
baseline, 30 seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
Title
change in covering grade
Description
percentage of the disk surface occupied by the biofilm
Time Frame
baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inmaculada Tomás Carmona, Senior lecturer
Phone
+34647344494
Email
inmaculada.tomas@usc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inmaculada Inmaculada, Senior lecturer
Organizational Affiliation
Faculty of Medicine and Dentistry of the University of Santiago de Compostela Santiago de Compostela, A Coruña, Spain, 15782
Official's Role
Study Director
Facility Information:
Facility Name
University of Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15782
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inmaculada Tomás Carmona, Senior Lecture
Phone
+34647344494
Email
inmaculada.tomas@usc.es

12. IPD Sharing Statement

Citations:
PubMed Identifier
26191050
Citation
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.
Results Reference
derived

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Methodology Antiseptic Application, Influence on Oral Biofilm.

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