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Trial record 16 of 237 for:    essential oil

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

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ClinicalTrials.gov Identifier: NCT02946801
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:

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.


Condition or disease Intervention/treatment Phase
Biofilms Oils, Essential Periodontitis Drug: Essential oils Drug: Essential oils without alcohol 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: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : November 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Listerine

Arm Intervention/treatment
Active Comparator: Essential oils mouthwash
20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1).
Drug: Essential oils
Other Name: Listerine Mentol

Experimental: essential oils without mouthwash
20 mL rinses for 30 seconds with essential oils without alcohol/2 times daily (1/0/1)
Drug: Essential oils without alcohol
Other Name: Listerine Zero

Sham Comparator: sterile water mouthwash
20 mL rinses for 30 seconds with sterile water/2 times daily (1/0/1)
Drug: Sterile water



Primary Outcome Measures :
  1. Percentage of bacterial viability [ Time Frame: 96 hours after the volunteer has worn the splints with the disks ]

Secondary Outcome Measures :
  1. Thickness in microns [ Time Frame: 96 hours after the volunteer has worn the splints with the disks ]
  2. Percentage of area covered by the biofilm [ Time Frame: 96 hours after the volunteer has worn the splints with the disks ]


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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: NCT02946801     History of Changes
Other Study ID Numbers: 395/2016
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:
Biofilms
essential oils
alcohol
microscopy, confocal
mouthwashes
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Ethanol
Listerine
Sodium Fluoride
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents