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

Study Overview
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Brief Summary
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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.

Official Title
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Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ. A Randomized Clinical Trial

Conditions
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Biofilms, Substantivity, Oils, Essential

Intervention / Treatment
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* Drug: essential oils
* Drug: essential oils without mouthwash
* Drug: sterile water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: essential oils<br>a single mouthwash with 20 ml of essential oils for 30 seconds. | Drug: essential oils<br> <br> * Other names: Listerine Mentol;|
| Experimental: essential oils without mouthwash<br>a single mouthwash with 20 ml of essential oils without alcohol for 30 seconds. | Drug: essential oils without mouthwash<br> <br> * Other names: Listerine Zero;|
| Sham Comparator: sterile water<br>a single mouthwash with 20 ml of sterile water for 30 seconds. | Drug: sterile water<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of bacterial viability |  | 48 hours after the volunteer has started to wear the splints | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thickness in microns |  | 48 hours after the volunteer has started to wear the splints | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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essential oils, microscope, colfocal, dental plaque