Immediate Effect and Substantivity of the Essential Oils Without Alcohol on the Oral Biofilm in Situ
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 21, 2016
CompletedFirst Posted
Study publicly available on registry
October 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedOctober 27, 2016
October 1, 2016
1 month
October 21, 2016
October 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of bacterial viability
48 hours after the volunteer has started to wear the splints
Secondary Outcomes (1)
thickness in microns
48 hours after the volunteer has started to wear the splints
Study Arms (3)
essential oils
ACTIVE COMPARATORa single mouthwash with 20 ml of essential oils for 30 seconds.
essential oils without mouthwash
EXPERIMENTALa single mouthwash with 20 ml of essential oils without alcohol for 30 seconds.
sterile water
SHAM COMPARATORa single mouthwash with 20 ml of sterile water for 30 seconds.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 24687247BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
October 21, 2016
First Posted
October 27, 2016
Study Start
October 1, 2016
Primary Completion
November 1, 2016
Last Updated
October 27, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share