NCT02946801

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

October 21, 2016

Last Update Submit

October 26, 2016

Conditions

BiofilmsOils, EssentialPeriodontitis

Keywords

Biofilmsessential oilsalcoholmicroscopy, confocalmouthwashes

Outcome Measures

Primary Outcomes (1)

  • Percentage of bacterial viability

    96 hours after the volunteer has worn the splints with the disks

Secondary Outcomes (2)

  • Thickness in microns

    96 hours after the volunteer has worn the splints with the disks

  • Percentage of area covered by the biofilm

    96 hours after the volunteer has worn the splints with the disks

Study Arms (3)

Essential oils mouthwash

ACTIVE COMPARATOR

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

Drug: Essential oils

essential oils without mouthwash

EXPERIMENTAL

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

Drug: Essential oils without alcohol

sterile water mouthwash

SHAM COMPARATOR

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

Drug: Sterile water

Interventions

Essential oilsDRUG
Also known as: Listerine Mentol
Essential oils mouthwash
Essential oils without alcoholDRUG
Also known as: Listerine Zero
essential oils without mouthwash
Sterile waterDRUG
sterile water mouthwash

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25689859BACKGROUND

MeSH Terms

Conditions

Periodontitis

Interventions

Oils, VolatileEthanol

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

OilsLipidsAlcoholsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 27, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share