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

NCT ID: NCT02946814

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Brief Summary

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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

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Conditions

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Biofilms Substantivity Oils, Essential

Keywords

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essential oils microscope, colfocal dental plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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essential oils

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

Group Type ACTIVE_COMPARATOR

essential oils

Intervention Type DRUG

essential oils without mouthwash

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

Group Type EXPERIMENTAL

essential oils without mouthwash

Intervention Type DRUG

sterile water

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

Group Type SHAM_COMPARATOR

sterile water

Intervention Type DRUG

Interventions

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essential oils

Intervention Type DRUG

essential oils without mouthwash

Intervention Type DRUG

sterile water

Intervention Type DRUG

Other Intervention Names

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Listerine Mentol Listerine Zero

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Santiago de Compostela

OTHER

Sponsor Role lead

Responsible Party

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Inmaculada Tomas

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Quintas V, Prada-Lopez I, Prados-Frutos JC, Tomas I. In situ antimicrobial activity on oral biofilm: essential oils vs. 0.2 % chlorhexidine. Clin Oral Investig. 2015 Jan;19(1):97-107. doi: 10.1007/s00784-014-1224-3. Epub 2014 Apr 1.

Reference Type BACKGROUND
PMID: 24687247 (View on PubMed)

Other Identifiers

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substantivity 2016

Identifier Type: -

Identifier Source: org_study_id