Methodology Antiseptic Application, Influence on Oral Biofilm.
Methodology of Application and Immediate Effect of the Essential Oils and 0.2% Chlorhexidine on Oral Biofilm: Immersion Versus Mouthwash.
1 other identifier
interventional
15
1 country
1
Brief Summary
The study has the objective to compare two different methodology of application the antiseptic on the oral biofilm will be formed during 48h in situ on a specific device. The first one using the immersion in the antiseptic solution, as much of the authors did in the past. And the second way doing a active mouthwash, as the manufacturer recommends. The study will compare two different antiseptic solutions, the chlorhexidine (0.2% Oraldine Perio) and the essential oils (Listerine Mentol) with the two different application and compared the bacterial vitality, thickness and covering grade between solutions and with a basal sample.
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
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 8, 2014
CompletedFirst Posted
Study publicly available on registry
October 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedOctober 23, 2014
October 1, 2014
1 month
October 8, 2014
October 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
change in bacterial vitality
percentage of live bacteria in the sample
baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
change in thickness
maximum numbers of layers (1micra per layer) with continuous presence of bacteria
baseline, 30 seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
change in covering grade
percentage of the disk surface occupied by the biofilm
baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
Study Arms (5)
Essential Oils, immersion
ACTIVE COMPARATORProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution
Chlorhexidine, immersion
ACTIVE COMPARATORProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution
baseline
OTHERProfessional oral cleaning Plaster cast IDODS Disk in basal conditions.
Essential Oils, mouthwash
ACTIVE COMPARATORProfessional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution
Chlorhexidine, mouthwash
ACTIVE COMPARATORProfessional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution
Interventions
A single, 30-second immersion in 1 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson \& Johnson, Madrid, Spain) (I-EO).
A single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2% CHX).
A single, 30-second mouthwash with 20 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson \& Johnson, Madrid, Spain) (M-EO).
A single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2% CHX).
scaling and polishing teeth of the volunteers
Taking a plaster cast of the volunteers' mouth
Specific intraoral device which carries six glass disks
Eligibility Criteria
You may qualify if:
- good oral health status: a minimum of 24 permanent teeth with no evidence of gingivitis or periodontitis and absence of untreated caries
You may not qualify if:
- smoker or former smoker
- presence of dental prostheses or orthodontic devices
- antibiotic treatment or routine use of oral antiseptics in the previous three months
- presence of any systemic disease that could alter the production or composition of saliva
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15782, Spain
Related Publications (1)
Prada-Lopez I, Quintas V, Casares-De-Cal MA, Suarez-Quintanilla JA, Suarez-Quintanilla D, Tomas I. Ex vivo vs. in vivo antibacterial activity of two antiseptics on oral biofilm. Front Microbiol. 2015 Jul 2;6:655. doi: 10.3389/fmicb.2015.00655. eCollection 2015.
PMID: 26191050DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Inmaculada Inmaculada, Senior lecturer
Faculty of Medicine and Dentistry of the University of Santiago de Compostela Santiago de Compostela, A Coruña, Spain, 15782
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior lecturer
Study Record Dates
First Submitted
October 8, 2014
First Posted
October 17, 2014
Study Start
October 1, 2014
Primary Completion
November 1, 2014
Last Updated
October 23, 2014
Record last verified: 2014-10