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

Phase 4

• Conditions: Biofilms; Substantivity; Oils, Essential
• Interventions: Drug: essential oils; Drug: essential oils without mouthwash; Drug: sterile water

• Registration Number: NCT02946814
• Lead Sponsor: University of Santiago de Compostela

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-25
• Last Update Submitted: 2016-10-25
• Study First Posted: 2016-10-27
• Last Update Posted: 2016-10-27
• Primary Completion: 2016-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
essential oils	essential oils	a single mouthwash with 20 ml of essential oils for 30 seconds.
essential oils without mouthwash	essential oils without mouthwash	a single mouthwash with 20 ml of essential oils without alcohol for 30 seconds.
sterile water	sterile water	a single mouthwash with 20 ml of sterile water for 30 seconds.

Primary Outcome Measures

Name	Time	Method
Percentage of bacterial viability	48 hours after the volunteer has started to wear the splints

Secondary Outcome Measures

Name	Time	Method
thickness in microns	48 hours after the volunteer has started to wear the splints