Methodology Antiseptic Application, Influence on Oral Biofilm.

Periodontitis Clinical Trial

Official title:

Methodology of Application and Immediate Effect of the Essential Oils and 0.2% Chlorhexidine on Oral Biofilm: Immersion Versus Mouthwash.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02267239
• Other study ID #: immersion vs. mouthwash
• Status: Recruiting
• Phase: Phase 4
• First received: October 8, 2014
• Last updated: October 22, 2014
• Start date: October 2014

Study information

• Verified date: October 2014
• Source: University of Santiago de Compostela
• Contact: Inmaculada Tomás Carmona, Senior lecturer
• Phone: +34647344494
• Email: inmaculada.tomas[@]usc.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Gingivitis
• Oral Biofilm
• Periodontitis

Intervention

Drug:
• essential 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).
• Chlorhexidine, immersion
A single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2% CHX).
• essential 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).
• chlorhexidine, mouthwash
A single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2% CHX).

Procedure:
• professional oral cleaning
scaling and polishing teeth of the volunteers
• Plaster cast
Taking a plaster cast of the volunteers' mouth

Device:
• IDODS
Specific intraoral device which carries six glass disks

Locations

Country	Name	City	State
Spain	University of Santiago de Compostela	Santiago de Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
University of Santiago de Compostela

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in bacterial vitality	percentage of live bacteria in the sample	baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)	Yes
Primary	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)	Yes
Primary	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)	Yes