Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth.
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|ClinicalTrials.gov Identifier: NCT02124655|
Recruitment Status : Completed
First Posted : April 28, 2014
Last Update Posted : April 29, 2014
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.
Chlorhexidine is considered the "gold standard" of oral antiseptics; nevertheless it has not been recommended for long periods of time due to its well-known secondary effects. All of these inconveniences have limited its acceptability among dental professionals and users; in contrast, however, are the exceptional antiseptic properties, promoting the interest of researchers in other alternative antiplaque agents. Mouthwashes containing essential oils in their formulation have received a lot of attention. Their antiplaque activity has been demonstrated in numerous clinical studies, in which they were used in conjunction with mechanical oral hygiene measures.
In order to achieve a better understanding of the clinical effects that antimicrobial agents produce in the interior of the biofilm, it is necessary to apply a methodology in which the biofilm grows directly in the interior of the oral cavity but its three dimensional structure is not distorted by manipulation.
The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (essential oils formulation and 0.2% chlorhexidine) 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|
|Oral Biofilm Mouthwash Periodontitis||Drug: Essential oils Drug: 0.2% chlorhexidine Drug: Sterile water||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth: a Randomised Clinical Trial.|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||June 2013|
Experimental: Essential oils/0.2% chlorhexidine/Sterile water
A) 20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1). -----14 days----- B) 10 mL rinses for 30 seconds with 0.2% chlorhexidine/2 times daily (1/0/1). -----14 days----- C) 20 mL rinses for 30 seconds with sterile water (1/0/1).
Drug: Essential oils
Other Name: Listerine
Drug: 0.2% chlorhexidine
Other Name: Oraldine Perio
Drug: Sterile water
- Bacterial vitality (%) [ Time Frame: 10 hours after the last mouthwash ]ratio of alive/dead bacteria.
- Biofilm thickness (microns) [ Time Frame: 10 hours after the last mouthwash ]thickness of the biofilm from the base of the substrate to the top surface of the biofilm
- covering grade (%) [ Time Frame: 10 hours after the last mouthwash ]area of the substrate that is covered by the biofilm after the 4 days of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124655
|Faculty of Medicine and Dentistry of the University of Santiago de Compostela|
|Santiago de Compostela, A Coruña, Spain, 15782|
|Principal Investigator:||Inmaculada Tomas||Senior lecturer at the University of Santiago de Compostela|