Methodology Antiseptic Application, Influence on Oral Biofilm.

Study Overview
=================
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).

Official Title
-----------------
Methodology of Application and Immediate Effect of the Essential Oils and 0.2% Chlorhexidine on Oral Biofilm: Immersion Versus Mouthwash.

Conditions
-----------------
Oral Biofilm, Periodontitis, Gingivitis

Intervention / Treatment
-----------------
* Drug: essential oils, immersion
* Drug: Chlorhexidine, immersion
* Drug: essential oils, mouthwash
* Drug: chlorhexidine, mouthwash
* Procedure: professional oral cleaning
* Procedure: Plaster cast
* Device: IDODS


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Essential Oils, immersion<br>Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution | Drug: essential oils, immersion<br>* A single, 30-second immersion in 1 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (I-EO).<br>* Other names: Listerine, Listerine Mentol, essential oil;Procedure: professional oral cleaning<br>* scaling and polishing teeth of the volunteers<br>* Other names: tartrectomy, scaling and polishing;Procedure: Plaster cast<br>* Taking a plaster cast of the volunteers' mouth<br>* Other names: model, dental impresionss;Device: IDODS<br>* Specific intraoral device which carries six glass disks<br>* Other names: Intraoral Device of Overlaid Disk-holding Splints;|
| Active Comparator: Chlorhexidine, immersion<br>Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution | Drug: Chlorhexidine, immersion<br>* A single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2% CHX).<br>* Other names: Oraldine Perio;Procedure: professional oral cleaning<br>* scaling and polishing teeth of the volunteers<br>* Other names: tartrectomy, scaling and polishing;Procedure: Plaster cast<br>* Taking a plaster cast of the volunteers' mouth<br>* Other names: model, dental impresionss;Device: IDODS<br>* Specific intraoral device which carries six glass disks<br>* Other names: Intraoral Device of Overlaid Disk-holding Splints;|
| Other: baseline<br>Professional oral cleaning Plaster cast IDODS Disk in basal conditions. | Procedure: professional oral cleaning<br>* scaling and polishing teeth of the volunteers<br>* Other names: tartrectomy, scaling and polishing;Procedure: Plaster cast<br>* Taking a plaster cast of the volunteers' mouth<br>* Other names: model, dental impresionss;Device: IDODS<br>* Specific intraoral device which carries six glass disks<br>* Other names: Intraoral Device of Overlaid Disk-holding Splints;|
| Active Comparator: Essential Oils, mouthwash<br>Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution | Drug: essential oils, mouthwash<br>* A single, 30-second mouthwash with 20 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (M-EO).<br>* Other names: Listerine, Listerine Mentol, essential oil;Procedure: professional oral cleaning<br>* scaling and polishing teeth of the volunteers<br>* Other names: tartrectomy, scaling and polishing;Procedure: Plaster cast<br>* Taking a plaster cast of the volunteers' mouth<br>* Other names: model, dental impresionss;Device: IDODS<br>* Specific intraoral device which carries six glass disks<br>* Other names: Intraoral Device of Overlaid Disk-holding Splints;|
| Active Comparator: Chlorhexidine, mouthwash<br>Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution | Drug: chlorhexidine, mouthwash<br>* A single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2% CHX).<br>* Other names: Oraldine perio;Procedure: professional oral cleaning<br>* scaling and polishing teeth of the volunteers<br>* Other names: tartrectomy, scaling and polishing;Procedure: Plaster cast<br>* Taking a plaster cast of the volunteers' mouth<br>* Other names: model, dental impresionss;Device: IDODS<br>* Specific intraoral device which carries six glass disks<br>* Other names: Intraoral Device of Overlaid Disk-holding Splints;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in bacterial vitality | percentage of live bacteria in the sample | 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 | 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 | baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
essential oils, chlorhexidine, microscopy, confocal, immersion, antiseptic