Clinical trial NCT02267239: Methodology Antiseptic Application, Influence on Oral Biofilm.
Official title: Methodology of Application and Immediate Effect of the Essential Oils and 0.2% Chlorhexidine on Oral Biofilm: Immersion Versus Mouthwash.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Oral Biofilm
Periodontitis
Gingivitis
Keywords: essential oils
chlorhexidine
microscopy, confocal
immersion
antiseptic
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: 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

Primary outcomes:
measure: change in bacterial vitality
timeFrame: baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
measure: change in thickness
timeFrame: baseline, 30 seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
measure: change in covering grade
timeFrame: baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: University of Santiago de Compostela
state: A Coruña
Study officials:
affiliation: Faculty of Medicine and Dentistry of the University of Santiago de Compostela Santiago de Compostela, A Coruña, Spain, 15782
name: Inmaculada Inmaculada, Senior lecturer
role: STUDY_DIRECTOR
References:
citation: 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.