Antiplaque Effect of Essential Oils With and Without Alcochol on an in Situ Model of Oral Biofilm Growth
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|ClinicalTrials.gov Identifier: NCT02946801|
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
The accumulation and maturation of oral biofilm in the gingival margin is widely recognised to be the primary aetiological factor in the development of chronic gingivitis. Based on this association, the current treatment of gingivitis is focused on biofilm disruption, which will normally include mechanical processes, both professionally and at home. However, for patients, it is not easy to achieve a proper level of plaque control. The efficient plaque control techniques are very time consuming and require a special motivation and skills for their optimum use. It was at this point where mouthwashes become important, due to the fact that they include diverse types of antimicrobial agents to complement the results of mechanical oral hygiene measures.
The essential oils have been presented as a realiable alternative to the "gold Standard" (Chlorhexidine). However, it use has been limited clinically due to their alcohol contain. Some years ago, a new alternative without alcohol has been launched to the market. This formulation has not been already deeply tested specific antiplaque studies in which the structure of the biofilm remained intact.
The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (based on an essential oils formulation with and without alcohol) in the short term with a posterior analysis on "non-destructured" biofilm with Confocal Laser Scanning Microscope combined with fluorescence staining.
|Condition or disease||Intervention/treatment||Phase|
|Biofilms Oils, Essential Periodontitis||Drug: Essential oils Drug: Essential oils without alcohol Drug: Sterile water||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth. A Randomized Clinical Trial|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2016|
Active Comparator: Essential oils mouthwash
20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1).
Drug: Essential oils
Other Name: Listerine Mentol
Experimental: essential oils without mouthwash
20 mL rinses for 30 seconds with essential oils without alcohol/2 times daily (1/0/1)
Drug: Essential oils without alcohol
Other Name: Listerine Zero
Sham Comparator: sterile water mouthwash
20 mL rinses for 30 seconds with sterile water/2 times daily (1/0/1)
Drug: Sterile water
- Percentage of bacterial viability [ Time Frame: 96 hours after the volunteer has worn the splints with the disks ]
- Thickness in microns [ Time Frame: 96 hours after the volunteer has worn the splints with the disks ]
- Percentage of area covered by the biofilm [ Time Frame: 96 hours after the volunteer has worn the splints with the disks ]