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
About this trial
This is an interventional prevention trial for Biofilms focused on measuring Biofilms, essential oils, alcohol, microscopy, confocal, mouthwashes
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.
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
NCT ID
NCT02946801
First Posted
October 21, 2016
Last Updated
October 26, 2016
Sponsor
University of Santiago de Compostela
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
background
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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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