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Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth.

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. Identifier: NCT02124655
Recruitment Status : Completed
First Posted : April 28, 2014
Last Update Posted : April 29, 2014
Johnson & Johnson
Information provided by (Responsible Party):
Inmaculada Tomas, University of Santiago de Compostela

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Bacterial vitality (%) [ Time Frame: 10 hours after the last mouthwash ]
    ratio of alive/dead bacteria.

  2. 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

  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Systemically healthy adults.
  • Minimum of 24 permanent teeth.
  • No gingivitis (Community Periodontal Index score = 0).
  • No periodontitis (Community Periodontal Index score = 0).
  • Absence of untreated caries.

Exclusion Criteria:

  • Smoker or former smoker.
  • Presence of dental prostheses.
  • Presence of orthodontic devices.
  • Antibiotic treatment or routine use of oral antiseptics in the previous 3 months.
  • Presence of any systemic disease that could alter the production or composition of saliva.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02124655

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Faculty of Medicine and Dentistry of the University of Santiago de Compostela
Santiago de Compostela, A Coruña, Spain, 15782
Sponsors and Collaborators
University of Santiago de Compostela
Johnson & Johnson
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Principal Investigator: Inmaculada Tomas Senior lecturer at the University of Santiago de Compostela
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Inmaculada Tomas, Senior Lecturer, University of Santiago de Compostela Identifier: NCT02124655    
Other Study ID Numbers: 393/2012
First Posted: April 28, 2014    Key Record Dates
Last Update Posted: April 29, 2014
Last Verified: April 2014
Keywords provided by Inmaculada Tomas, University of Santiago de Compostela:
Microscopy, confocal
Dental plaque
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents, Local
Anti-Infective Agents