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Essential Oils With and Without Alcohol: Substantivity and Antiplaque Effect

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ClinicalTrials.gov Identifier: NCT03146390
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Inmaculada Tomas, University of Santiago de Compostela

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.


Condition or disease Intervention/treatment Phase
Oral Biofilm Dental Plaque Periodontitis Drug: Essential oils Drug: Alcohol free essential oils Other: Water Phase 4

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: Essential Oils With and Without Alcohol: in Vivo Antibacterial Effect
Actual Study Start Date : May 2, 2017
Estimated Primary Completion Date : July 31, 2017
Estimated Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Listerine

Arm Intervention/treatment
Active Comparator: Essential oils (Listerine Mentol)
  1. a single mouthwash with 20 ml of essential oils for 30 seconds
  2. 20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1).
Drug: Essential oils
all subjects will perform all interventions of all arms
Other Name: Listerine Mentol

Placebo Comparator: Water
  1. a single mouthwash with 20 ml of sterile water for 30 seconds
  2. 20 ml rinses for 30 seconds with sterile water/2 times daily (1/0/1).
Other: Water
all subjects will perform all interventions of all arms
Other Name: Sterile Water

Experimental: Alcohol free essential oils
  1. a single mouthwash with 20 ml of alcohol free essential oils for 30 seconds
  2. 20 ml rinses for 30 seconds with alcohol free essential oils/2 times daily (1/0/1).
Drug: Alcohol free essential oils
all subjects will perform all interventions of all arms
Other Name: Listerine Zero




Primary Outcome Measures :
  1. Change in the Bacterial viability (%) (substantivity) [ Time Frame: Baseline, 30 seconds, 1 hour, 3 hours, 5 hours and 7 hours after the single application ]
    ratio of alive/dead bacteria

  2. Bacterial viability (%) (antiplaque effect) [ Time Frame: 10 hours after the last mouthwash ]
    ratio of alive/dead bacteria

  3. Change in the Biofilm Thickness (Microns) (substantivity) [ Time Frame: baseline, 30 seconds, 1 hour, 3 hours, 5 hours and 7 hours after the single application ]
    thickness of the biofilm from the base of the substrate to the top surface of the biofilm

  4. Biofilm Thickness (Microns) (Antiplaque effect) [ Time Frame: 10 hours after the last mouthwash ]
    thickness of the biofilm from the base of the substrate to the top surface of the biofilm

  5. Covering Grade (%) (antiplaque effect) [ Time Frame: 10 hours after the last mouthwash ]
    area of the substrate that is covered by the biofilm after the 4 days of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146390


Contacts
Contact: Inmaculada Tomás, Senior Lecturer +34981560031 ext 12344 victor.quintas@usc.es

Locations
Spain
University of Santiago de Compostela Recruiting
Santiago de Compostela, A Coruña, Spain, 15782
Contact: Inmaculada Tomás, Senior Lecturer    +34981560031 ext 1234    victor.quintas@usc.es   
Sponsors and Collaborators
University of Santiago de Compostela

Publications:
Responsible Party: Inmaculada Tomas, Senior Lecturer, University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT03146390     History of Changes
Other Study ID Numbers: 023/2017
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Inmaculada Tomas, University of Santiago de Compostela:
biofilms
essential oils
microscopy, confocal
mouthwashes

Additional relevant MeSH terms:
Periodontitis
Dental Plaque
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Ethanol
Listerine
Sodium Fluoride
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents