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Trial record 93 of 291 for:    Sodium Fluoride OR Duraphat

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

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ClinicalTrials.gov Identifier: NCT02946814
Recruitment Status : Unknown
Verified October 2016 by Inmaculada Tomas, University of Santiago de Compostela.
Recruitment status was:  Not yet recruiting
First Posted : October 27, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Inmaculada Tomas, University of Santiago de Compostela

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Biofilms Substantivity Oils, Essential Drug: essential oils Drug: essential oils without mouthwash Drug: sterile water Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ. A Randomized Clinical Trial
Study Start Date : October 2016
Estimated Primary Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Listerine

Arm Intervention/treatment
Active Comparator: essential oils
a single mouthwash with 20 ml of essential oils for 30 seconds.
Drug: essential oils
Other Name: 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 Name: Listerine Zero

Sham Comparator: sterile water
a single mouthwash with 20 ml of sterile water for 30 seconds.
Drug: sterile water



Primary Outcome Measures :
  1. Percentage of bacterial viability [ Time Frame: 48 hours after the volunteer has started to wear the splints ]

Secondary Outcome Measures :
  1. thickness in microns [ Time Frame: 48 hours after the volunteer has started to wear the splints ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Publications:
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Responsible Party: Inmaculada Tomas, Senior Lecturer, University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT02946814     History of Changes
Other Study ID Numbers: substantivity 2016
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Inmaculada Tomas, University of Santiago de Compostela:
essential oils
microscope, colfocal
dental plaque
Additional relevant MeSH terms:
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Listerine
Sodium Fluoride
Anti-Infective Agents, Local
Anti-Infective Agents
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents