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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essential Oils, immersion | Active Comparator | Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution |
|
| Chlorhexidine, immersion | Active Comparator | Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution |
|
| baseline | Other | Professional oral cleaning Plaster cast IDODS Disk in basal conditions. |
|
| Essential Oils, mouthwash | Active Comparator | Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution |
|
| Chlorhexidine, mouthwash | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| essential oils, immersion | Drug | A single, 30-second immersion in 1 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (I-EO). |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inmaculada Tomás Carmona, Senior lecturer | Contact | +34647344494 | inmaculada.tomas@usc.es |
| Name | Affiliation | Role |
|---|---|---|
| Inmaculada Inmaculada, Senior lecturer | Faculty of Medicine and Dentistry of the University of Santiago de Compostela Santiago de Compostela, A Coruña, Spain, 15782 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Santiago de Compostela | Recruiting | Santiago de Compostela | A Coruña | 15782 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26191050 | Derived | 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. |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009822 | Oils, Volatile |
| D007101 | Immersion |
| C057473 | Listerine |
| D002710 | Chlorhexidine |
| D009067 | Mouthwashes |
| D014080 | Tooth Exfoliation |
| D002370 | Casts, Surgical |
| D008954 | Models, Biological |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D008919 | Investigative Techniques |
| D001645 | Biguanides |
| D006146 |
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Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution |
|
|
| Chlorhexidine, immersion | Drug | A single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2% CHX). |
|
|
| essential oils, mouthwash | Drug | A single, 30-second mouthwash with 20 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (M-EO). |
|
|
| chlorhexidine, mouthwash | Drug | A single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2% CHX). |
|
|
| professional oral cleaning | Procedure | scaling and polishing teeth of the volunteers |
|
|
| Plaster cast | Procedure | Taking a plaster cast of the volunteers' mouth |
|
|
| IDODS | Device | Specific intraoral device which carries six glass disks |
|
|
| D005882 |
| Gingival Diseases |
| Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D001697 | Biomedical and Dental Materials |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D003358 | Cosmetics |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D016267 | External Fixators |
| D009984 | Orthopedic Fixation Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D053831 | Surgical Fixation Devices |
| D008962 | Models, Theoretical |