Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth.
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 24, 2014
CompletedFirst Posted
Study publicly available on registry
April 28, 2014
CompletedApril 29, 2014
April 1, 2014
9 months
April 24, 2014
April 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Bacterial vitality (%)
ratio of alive/dead bacteria.
10 hours after the last mouthwash
Biofilm thickness (microns)
thickness of the biofilm from the base of the substrate to the top surface of the biofilm
10 hours after the last mouthwash
covering grade (%)
area of the substrate that is covered by the biofilm after the 4 days of treatment
10 hours after the last mouthwash
Study Arms (1)
Essential oils/0.2% chlorhexidine/Sterile water
EXPERIMENTALA) 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).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Santiago de Compostelalead
- Johnson & Johnsoncollaborator
Study Sites (1)
Faculty of Medicine and Dentistry of the University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15782, Spain
Related Publications (3)
Garcia-Caballero L, Quintas V, Prada-Lopez I, Seoane J, Donos N, Tomas I. Chlorhexidine substantivity on salivary flora and plaque-like biofilm: an in situ model. PLoS One. 2013 Dec 27;8(12):e83522. doi: 10.1371/journal.pone.0083522. eCollection 2013.
PMID: 24386220BACKGROUNDQuintas V, Prada-Lopez I, Prados-Frutos JC, Tomas I. In situ antimicrobial activity on oral biofilm: essential oils vs. 0.2 % chlorhexidine. Clin Oral Investig. 2015 Jan;19(1):97-107. doi: 10.1007/s00784-014-1224-3. Epub 2014 Apr 1.
PMID: 24687247BACKGROUNDQuintas V, Prada-Lopez I, Donos N, Suarez-Quintanilla D, Tomas I. Antiplaque effect of essential oils and 0.2% chlorhexidine on an in situ model of oral biofilm growth: a randomised clinical trial. PLoS One. 2015 Feb 17;10(2):e0117177. doi: 10.1371/journal.pone.0117177. eCollection 2015.
PMID: 25689859DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inmaculada Tomas
Senior lecturer at the University of Santiago de Compostela
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
April 24, 2014
First Posted
April 28, 2014
Study Start
September 1, 2012
Primary Completion
June 1, 2013
Last Updated
April 29, 2014
Record last verified: 2014-04