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Antiplaque Effect of Essential Oils With and Without Alcochol on an in Situ Model of Oral Biofilm Growth

NCT ID: NCT02946801

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

2016-11-30

Study Completion Date

2016-12-31

Brief Summary

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The accumulation and maturation of oral biofilm in the gingival margin is widely recognised to be the primary aetiological factor in the development of chronic gingivitis. Based on this association, the current treatment of gingivitis is focused on biofilm disruption, which will normally include mechanical processes, both professionally and at home. However, for patients, it is not easy to achieve a proper level of plaque control. The efficient plaque control techniques are very time consuming and require a special motivation and skills for their optimum use. It was at this point where mouthwashes become important, due to the fact that they include diverse types of antimicrobial agents to complement the results of mechanical oral hygiene measures.

The essential oils have been presented as a realiable alternative to the "gold Standard" (Chlorhexidine). However, it use has been limited clinically due to their alcohol contain. Some years ago, a new alternative without alcohol has been launched to the market. This formulation has not been already deeply tested specific antiplaque studies in which the structure of the biofilm remained intact.

The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (based on an essential oils formulation with and without alcohol) in the short term with a posterior analysis on "non-destructured" biofilm with Confocal Laser Scanning Microscope combined with fluorescence staining.

Detailed Description

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Conditions

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Biofilms Oils, Essential Periodontitis

Keywords

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Biofilms essential oils alcohol microscopy, confocal mouthwashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Essential oils mouthwash

20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1).

Group Type ACTIVE_COMPARATOR

Essential oils

Intervention Type DRUG

essential oils without mouthwash

20 mL rinses for 30 seconds with essential oils without alcohol/2 times daily (1/0/1)

Group Type EXPERIMENTAL

Essential oils without alcohol

Intervention Type DRUG

sterile water mouthwash

20 mL rinses for 30 seconds with sterile water/2 times daily (1/0/1)

Group Type SHAM_COMPARATOR

Sterile water

Intervention Type DRUG

Interventions

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Essential oils

Intervention Type DRUG

Essential oils without alcohol

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, Donos N, Suarez-Quintanilla D, Tomas I. Antiplaque effect of essential oils and 0.2% chlorhexidine on an in situ model of oral biofilm growth: a randomised clinical trial. PLoS One. 2015 Feb 17;10(2):e0117177. doi: 10.1371/journal.pone.0117177. eCollection 2015.

Reference Type BACKGROUND
PMID: 25689859 (View on PubMed)

Other Identifiers

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395/2016

Identifier Type: -

Identifier Source: org_study_id