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Methodology Antiseptic Application, Influence on Oral Biofilm.

Phase 4
Conditions
Oral Biofilm
Periodontitis
Gingivitis
Interventions
Drug: essential oils, immersion
Drug: Chlorhexidine, immersion
Drug: chlorhexidine, mouthwash
Drug: essential oils, mouthwash
Procedure: professional oral cleaning
Procedure: Plaster cast
Device: IDODS
Registration Number
NCT02267239
Lead Sponsor
University of Santiago de Compostela
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.

Detailed Description

15 healthy volunteers, between 20 and 45 years old, will use during 48 hours two specific oral devices with 3 glass disks each. After this period, one of the disk will be drawn from the device and it will be immersed in Live/Dead BacLight solution for 15 minutes and then the disk will be analysed by the Confocal Laser Scanning Microscope (CLSM). Immediately, another disk will be removed from the intraoral device and immersed in the antiseptic solution, being analysed by the CLSM as well. After that, the volunteers will do the mouthwash with the antiseptic solution (as stated in the specific protocol) and the last disk will be drawn from the device and will be analysed by the CLSM following the same protocol. The other 3 disk will undergo the same protocol of baseline, immersion and mouthwash, but with the other antiseptic solution.

The CLSM data will be analysed and the bacterial vitality, thickness and covering grade will be calculated. Finally the statistical analysis will be applied (Pairwise comparisons, with the Bonferroni adjustment).

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
15
Inclusion Criteria
  • good oral health status: a minimum of 24 permanent teeth with no evidence of gingivitis or periodontitis and absence of untreated caries
Exclusion Criteria
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Essential Oils, immersionessential oils, immersionProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution
Essential Oils, immersionIDODSProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution
Chlorhexidine, immersionChlorhexidine, immersionProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution
Chlorhexidine, immersionprofessional oral cleaningProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution
Chlorhexidine, immersionIDODSProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution
baselinePlaster castProfessional oral cleaning Plaster cast IDODS Disk in basal conditions.
Chlorhexidine, mouthwashchlorhexidine, mouthwashProfessional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution
Chlorhexidine, mouthwashprofessional oral cleaningProfessional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution
Essential Oils, mouthwashessential oils, mouthwashProfessional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution
Chlorhexidine, mouthwashPlaster castProfessional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution
Essential Oils, immersionprofessional oral cleaningProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution
baselineprofessional oral cleaningProfessional oral cleaning Plaster cast IDODS Disk in basal conditions.
baselineIDODSProfessional oral cleaning Plaster cast IDODS Disk in basal conditions.
Essential Oils, mouthwashPlaster castProfessional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution
Essential Oils, mouthwashprofessional oral cleaningProfessional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution
Essential Oils, mouthwashIDODSProfessional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution
Chlorhexidine, mouthwashIDODSProfessional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution
Essential Oils, immersionPlaster castProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution
Chlorhexidine, immersionPlaster castProfessional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution
Primary Outcome Measures
NameTimeMethod
change in bacterial vitalitybaseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)

percentage of live bacteria in the sample

change in thicknessbaseline, 30 seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)

maximum numbers of layers (1micra per layer) with continuous presence of bacteria

change in covering gradebaseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)

percentage of the disk surface occupied by the biofilm

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Santiago de Compostela

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Santiago de Compostela, A Coruña, Spain

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