Methodology Antiseptic Application, Influence on Oral Biofilm.

University of Santiago de Compostela

Status and phase: Unknown; Phase 4

Conditions: Periodontitis; Oral Biofilm; Gingivitis

Treatments: Drug: Chlorhexidine, immersion; Drug: chlorhexidine, mouthwash; Procedure: Plaster cast; Device: IDODS; Drug: essential oils, immersion; Procedure: professional oral cleaning; Drug: essential oils, mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT02267239

immersion vs. mouthwash

Details and patient eligibility

About

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.

Full 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).

Enrollment: 15 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

15 participants in 5 patient groups

Essential Oils, immersion

Active Comparator group

Description:

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution

Treatment:

Procedure: professional oral cleaning

Device: IDODS

Procedure: Plaster cast

Drug: essential oils, immersion

Chlorhexidine, immersion

Active Comparator group

Description:

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution

Treatment:

Procedure: professional oral cleaning

Device: IDODS

Procedure: Plaster cast

Drug: Chlorhexidine, immersion

baseline

Other group

Description:

Professional oral cleaning Plaster cast IDODS Disk in basal conditions.

Treatment:

Procedure: professional oral cleaning

Device: IDODS

Procedure: Plaster cast

Essential Oils, mouthwash

Active Comparator group

Description:

Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution

Treatment:

Procedure: professional oral cleaning

Device: IDODS

Procedure: Plaster cast

Drug: essential oils, mouthwash

Chlorhexidine, mouthwash

Active Comparator group

Description:

Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution

Treatment:

Procedure: professional oral cleaning

Device: IDODS

Procedure: Plaster cast

Drug: chlorhexidine, mouthwash