Essential Oils With and Without Alcohol: Substantivity and Antiplaque Effect
Primary Purpose
Oral Biofilm, Dental Plaque, Periodontitis
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Essential oils
Alcohol free essential oils
Water
Sponsored by
About this trial
This is an interventional prevention trial for Oral Biofilm focused on measuring biofilms, essential oils, 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
- University of Santiago de CompostelaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Experimental
Arm Label
Essential oils (Listerine Mentol)
Water
Alcohol free essential oils
Arm Description
a single mouthwash with 20 ml of essential oils for 30 seconds 20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1).
a single mouthwash with 20 ml of sterile water for 30 seconds 20 ml rinses for 30 seconds with sterile water/2 times daily (1/0/1).
a single mouthwash with 20 ml of alcohol free essential oils for 30 seconds 20 ml rinses for 30 seconds with alcohol free essential oils/2 times daily (1/0/1).
Outcomes
Primary Outcome Measures
Change in the Bacterial viability (%) (substantivity)
ratio of alive/dead bacteria
Bacterial viability (%) (antiplaque effect)
ratio of alive/dead bacteria
Change in the Biofilm Thickness (Microns) (substantivity)
thickness of the biofilm from the base of the substrate to the top surface of the biofilm
Biofilm Thickness (Microns) (Antiplaque effect)
thickness of the biofilm from the base of the substrate to the top surface of the biofilm
Covering Grade (%) (antiplaque effect)
area of the substrate that is covered by the biofilm after the 4 days of treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03146390
First Posted
April 30, 2017
Last Updated
May 8, 2017
Sponsor
University of Santiago de Compostela
1. Study Identification
Unique Protocol Identification Number
NCT03146390
Brief Title
Essential Oils With and Without Alcohol: Substantivity and Antiplaque Effect
Official Title
Essential Oils With and Without Alcohol: in Vivo Antibacterial Effect
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Anticipated)
Study Completion Date
August 31, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santiago de Compostela
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Essential oils (EO) are composed by a wide diversity of products. Therefore, their antimicrobial activity will be related to their composition, configuration, amount and their possible interaction. The traditional formulation containing EO (T-EO) is a complex mixture of phenolic compounds combined with determinate EO: 0.092% of eucalyptol, 0.064% of thymol, 0.06% of methyl-salicylate and y 0.042% of menthol. All of this solved in a hydroalcoholic vehicle containing from a 21.6% to a 26.9% of alcohol. Thus, T-EO contain ethanol, which is a chemical compound used in order to dissolve and stabilize the numerous substances present in the rinse. The concentration of ethanol present in the T-EO rinses, as previously said, is more than 20%. This concentration of ethanol, higher than 20%, is been found sufficient to dissolve the EO but insufficient to have a direct antibacterial effect. In fact, the manufacturer presents the alcohol contain (21.6%), among others, as an inactive ingredient in its formula. Over the years, the adequacy of the use of ethanol in mouthwashes, as well as their effects on the surfaces of composite restorations and their possible role in development of oropharyngeal cancer have been discussed. Although a direct cause-and-effect correlation between the development of oropharyngeal carcinoma and the use of alcohol-based rinses has not been demonstrated and probably it will never be (at least by epidemiological studies), it is considered desirable to eliminate ethanol from daily mouthwashes, especially for those patients at higher risk. Furthermore, the fact that the alcohol is present in its formula, have produced that some clinical practitioners do not prescribe the traditional formula due to the controversy of the issue. All this have lead to the development of new, alcohol free formulations of EO (Af-EO).
The composition of the Af-EO is exactly the same in their active ingredients (Eucalyptol, Thymol, Methyl-salycilate and Menthol), but sodium fluoride has been added. Some differences are found in their inactive ingredients. These are based on the alcohol containing of the T-EO, without presence in the Af-EO and the presence of Propylene Glycol, sodium lauryl sulfate and sucralose in the Af-EO, without presence in the T-EO.
In order to measure the efficacy of a mouthwash against the dental plaque two different concepts should be defined: the substantivity and antiplaque effect. The substantivity of an oral antiseptic is defined as the prolonged adherence to the oral surfaces and its slow release at effective doses which guarantee the persistence of the antimicrobial activity. The more substantivity an oral antiseptic has the better. For its study in vivo, the most popular models are those which analyze the effect that a single mouthwash has in a mature biofilm.
The second aspect that should be studied from an oral antiseptic, the antiplaque effect, is defined as the capacity that an agent has to avoid the formation of bacterial aggregates (plaque) on the oral surfaces. For its study in vivo, models start from a baseline sample with levels of plaque near to 0 in order to assess the power of the antiseptic to reduce the formation of bacterial plaque (normally dental plaque) against the control. A clinical study of 6 months using a determinate antiplaque agent is necessary in order to tag an antiseptic as effective. However, in the literature, there is an established model of 4 days of plaque regrowing which can assess the inhibitory activity that the mouthwashes have per se; furthermore, it determines the relative efficacy of the different formulations being considered as predictable of the antiplaque effect of an antiseptic.
In addition, another important factor in the study in vivo of an oral antiseptic is the necessity to conserve intact the oral biofilm at all stages: formation, recollection and analysis of the oral samples. This is in order not to interfere the delicate three dimensional structure of the oral biofilm which has been proven to be essential in the resistance to the effects of an external antiseptic agent. For these reasons, the study of the oral biofilm with the help of intraoral disks hold in specially designed apparatus combined with the application of the Confocal Laser Scanning Microscopy have proved to be very valuable at the study of the oral biofilm in its intact hydrated natural state.
Since an alcohol free formulation of the EO have come up to the market, it seems convenient to compare its effects to the traditional one. Although some studies comparing the effects of T-EO and Af-EO have been found, none of them assessed and compared their substantivity and antiplaque effect in an in vivo model of structured oral biofilm. For this reason, the aim of the present study was to compare the in vivo antibacterial effect (immediate effect, substantivity and antiplaque effect) of the EO with and without alcohol in structured oral biofilm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Biofilm, Dental Plaque, Periodontitis
Keywords
biofilms, essential oils, 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 (Listerine Mentol)
Arm Type
Active Comparator
Arm Description
a single mouthwash with 20 ml of essential oils for 30 seconds
20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1).
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
a single mouthwash with 20 ml of sterile water for 30 seconds
20 ml rinses for 30 seconds with sterile water/2 times daily (1/0/1).
Arm Title
Alcohol free essential oils
Arm Type
Experimental
Arm Description
a single mouthwash with 20 ml of alcohol free essential oils for 30 seconds
20 ml rinses for 30 seconds with alcohol free essential oils/2 times daily (1/0/1).
Intervention Type
Drug
Intervention Name(s)
Essential oils
Other Intervention Name(s)
Listerine Mentol
Intervention Description
all subjects will perform all interventions of all arms
Intervention Type
Drug
Intervention Name(s)
Alcohol free essential oils
Other Intervention Name(s)
Listerine Zero
Intervention Description
all subjects will perform all interventions of all arms
Intervention Type
Other
Intervention Name(s)
Water
Other Intervention Name(s)
Sterile Water
Intervention Description
all subjects will perform all interventions of all arms
Primary Outcome Measure Information:
Title
Change in the Bacterial viability (%) (substantivity)
Description
ratio of alive/dead bacteria
Time Frame
Baseline, 30 seconds, 1 hour, 3 hours, 5 hours and 7 hours after the single application
Title
Bacterial viability (%) (antiplaque effect)
Description
ratio of alive/dead bacteria
Time Frame
10 hours after the last mouthwash
Title
Change in the Biofilm Thickness (Microns) (substantivity)
Description
thickness of the biofilm from the base of the substrate to the top surface of the biofilm
Time Frame
baseline, 30 seconds, 1 hour, 3 hours, 5 hours and 7 hours after the single application
Title
Biofilm Thickness (Microns) (Antiplaque effect)
Description
thickness of the biofilm from the base of the substrate to the top surface of the biofilm
Time Frame
10 hours after the last mouthwash
Title
Covering Grade (%) (antiplaque effect)
Description
area of the substrate that is covered by the biofilm after the 4 days of treatment
Time Frame
10 hours after the last mouthwash
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inmaculada Tomás, Senior Lecturer
Phone
+34981560031
Ext
12344
Email
victor.quintas@usc.es
Facility Information:
Facility Name
University of Santiago de Compostela
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15782
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inmaculada Tomás, Senior Lecturer
Phone
+34981560031
Ext
1234
Email
victor.quintas@usc.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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
PubMed Identifier
24687247
Citation
Quintas V, Prada-Lopez I, Prados-Frutos JC, Tomas I. In situ antimicrobial activity on oral biofilm: essential oils vs. 0.2 % chlorhexidine. Clin Oral Investig. 2015 Jan;19(1):97-107. doi: 10.1007/s00784-014-1224-3. Epub 2014 Apr 1.
Results Reference
background
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Essential Oils With and Without Alcohol: Substantivity and Antiplaque Effect
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