Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02946814|
Recruitment Status : Unknown
Verified October 2016 by Inmaculada Tomas, University of Santiago de Compostela.
Recruitment status was: Not yet recruiting
First Posted : October 27, 2016
Last Update Posted : October 27, 2016
This study aims to evaluate the in situ antibacterial activity of a mouthwash containing essential oils with and without alcohol on undisturbed de novo plaque-like biofilm (PL-biofilm) up to 7 h after its application.
An appliance was designed to hold six glass disks on the buccal sides of the lower teeth, allowing PL-biofilm growth. Twenty healthy volunteers will the appliance for 48 h and then performed a mouthwash with essential oils. Disks will be removed after 30 s and at 1, 3, 5, and 7 h later. After a washout period, the same procedure will be repeated with a sterile water mouthwash and a mouthwash with essential oils without alcohol. After PL-biofilm vital staining, samples will be analyzed using a confocal laser scanning microscope analysing their bacterial viability and thickness.
|Condition or disease||Intervention/treatment||Phase|
|Biofilms Substantivity Oils, Essential||Drug: essential oils Drug: essential oils without mouthwash Drug: sterile water||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ. A Randomized Clinical Trial|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||November 2016|
Active Comparator: essential oils
a single mouthwash with 20 ml of essential oils for 30 seconds.
Drug: essential oils
Other Name: Listerine Mentol
Experimental: essential oils without mouthwash
a single mouthwash with 20 ml of essential oils without alcohol for 30 seconds.
Drug: essential oils without mouthwash
Other Name: Listerine Zero
Sham Comparator: sterile water
a single mouthwash with 20 ml of sterile water for 30 seconds.
Drug: sterile water
- Percentage of bacterial viability [ Time Frame: 48 hours after the volunteer has started to wear the splints ]
- thickness in microns [ Time Frame: 48 hours after the volunteer has started to wear the splints ]