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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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02267239
Enrollment
15
Registered
2014-10-17
Start date
2014-10-31
Completion date
Unknown
Last updated
2014-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Biofilm, Periodontitis, Gingivitis

Keywords

essential oils, chlorhexidine, microscopy, confocal, immersion, antiseptic

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).

Interventions

DRUGessential oils, immersion

A single, 30-second immersion in 1 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (I-EO).

DRUGChlorhexidine, immersion

A single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2% CHX).

DRUGessential oils, mouthwash

A single, 30-second mouthwash with 20 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (M-EO).

DRUGchlorhexidine, mouthwash

A single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2% CHX).

PROCEDUREprofessional oral cleaning

scaling and polishing teeth of the volunteers

PROCEDUREPlaster cast

Taking a plaster cast of the volunteers' mouth

DEVICEIDODS

Specific intraoral device which carries six glass disks

Sponsors

University of Santiago de Compostela
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

Countries

Spain

Contacts

Primary ContactInmaculada Tomás Carmona, Senior lecturer
inmaculada.tomas@usc.es+34647344494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026