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

Primary Purpose

Biofilms, Oils, Essential, Periodontitis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Essential oils
Essential oils without alcohol
Sterile water
Sponsored by
University of Santiago de Compostela
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Biofilms focused on measuring Biofilms, essential oils, alcohol, microscopy, confocal, mouthwashes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Sham Comparator

    Arm Label

    Essential oils mouthwash

    essential oils without mouthwash

    sterile water mouthwash

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    Percentage of bacterial viability

    Secondary Outcome Measures

    Thickness in microns
    Percentage of area covered by the biofilm

    Full Information

    First Posted
    October 21, 2016
    Last Updated
    October 26, 2016
    Sponsor
    University of Santiago de Compostela
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02946801
    Brief Title
    Antiplaque Effect of Essential Oils With and Without Alcochol on an in Situ Model of Oral Biofilm Growth
    Official Title
    Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth. A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2016 (undefined)
    Primary Completion Date
    November 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Santiago de Compostela

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Biofilms, Oils, Essential, Periodontitis
    Keywords
    Biofilms, essential oils, alcohol, microscopy, confocal, mouthwashes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Essential oils mouthwash
    Arm Type
    Active Comparator
    Arm Description
    20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1).
    Arm Title
    essential oils without mouthwash
    Arm Type
    Experimental
    Arm Description
    20 mL rinses for 30 seconds with essential oils without alcohol/2 times daily (1/0/1)
    Arm Title
    sterile water mouthwash
    Arm Type
    Sham Comparator
    Arm Description
    20 mL rinses for 30 seconds with sterile water/2 times daily (1/0/1)
    Intervention Type
    Drug
    Intervention Name(s)
    Essential oils
    Other Intervention Name(s)
    Listerine Mentol
    Intervention Type
    Drug
    Intervention Name(s)
    Essential oils without alcohol
    Other Intervention Name(s)
    Listerine Zero
    Intervention Type
    Drug
    Intervention Name(s)
    Sterile water
    Primary Outcome Measure Information:
    Title
    Percentage of bacterial viability
    Time Frame
    96 hours after the volunteer has worn the splints with the disks
    Secondary Outcome Measure Information:
    Title
    Thickness in microns
    Time Frame
    96 hours after the volunteer has worn the splints with the disks
    Title
    Percentage of area covered by the biofilm
    Time Frame
    96 hours after the volunteer has worn the splints with the disks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25689859
    Citation
    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.
    Results Reference
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    Antiplaque Effect of Essential Oils With and Without Alcochol on an in Situ Model of Oral Biofilm Growth

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