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

October 25, 2016 updated by: Inmaculada Tomas, University of Santiago de Compostela

Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ. A Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: essential oils
a single mouthwash with 20 ml of essential oils for 30 seconds.
Drug: essential oils
Other Names:
  • Listerine Mentol
Experimental: essential oils without mouthwash
a single mouthwash with 20 ml of essential oils without alcohol for 30 seconds.
Drug: essential oils without mouthwash
Other Names:
  • Listerine Zero
Sham Comparator: sterile water
a single mouthwash with 20 ml of sterile water for 30 seconds.
Drug: sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of bacterial viability
Time Frame: 48 hours after the volunteer has started to wear the splints
48 hours after the volunteer has started to wear the splints

Secondary Outcome Measures

Outcome Measure
Time Frame
thickness in microns
Time Frame: 48 hours after the volunteer has started to wear the splints
48 hours after the volunteer has started to wear the splints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Santiago de Compostela

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

October 21, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • substantivity 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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