Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ

University of Santiago de Compostela

Status and phase: Unknown; Phase 4

Conditions: Oils, Essential; Biofilms; Substantivity

Treatments: Drug: essential oils; Drug: sterile water; Drug: essential oils without mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT02946814

substantivity 2016

Details and patient eligibility

About

This study aims to evaluate the in situ antibacterial activity of a mouthwash containing essential oils with and without alcohol on undisturbed de novo plaque-like biofilm (PL-biofilm) up to 7 h after its application.

An appliance was designed to hold six glass disks on the buccal sides of the lower teeth, allowing PL-biofilm growth. Twenty healthy volunteers will the appliance for 48 h and then performed a mouthwash with essential oils. Disks will be removed after 30 s and at 1, 3, 5, and 7 h later. After a washout period, the same procedure will be repeated with a sterile water mouthwash and a mouthwash with essential oils without alcohol. After PL-biofilm vital staining, samples will be analyzed using a confocal laser scanning microscope analysing their bacterial viability and thickness.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Systemically healthy adults.

• Minimum of 24 permanent teeth.
• No gingivitis (Community Periodontal Index score = 0).
• No periodontitis (Community Periodontal Index score = 0).
• Absence of untreated caries.

Exclusion criteria

• Smoker or former smoker.
• Presence of dental prostheses.
• Presence of orthodontic devices.
• Antibiotic treatment or routine use of oral antiseptics in the previous 3 months.
• Presence of any systemic disease that could alter the production or composition of saliva.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 3 patient groups

essential oils

Active Comparator group

Description:

a single mouthwash with 20 ml of essential oils for 30 seconds.

Treatment:

Drug: essential oils

essential oils without mouthwash

Experimental group

Description:

a single mouthwash with 20 ml of essential oils without alcohol for 30 seconds.

Treatment:

Drug: essential oils without mouthwash

sterile water

Sham Comparator group

Description:

a single mouthwash with 20 ml of sterile water for 30 seconds.

Treatment:

Drug: sterile water