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

Biofilms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02946814
• Other study ID #: substantivity 2016
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 21, 2016
• Last updated: October 25, 2016
• Start date: October 2016

Study information

• Verified date: October 2016
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Biofilms
• Oils, Essential
• Substantivity

Intervention

Drug:
• essential oils

• essential oils without mouthwash

• sterile water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Santiago de Compostela

References & Publications (1)

Quintas V, Prada-López I, Prados-Frutos JC, Tomás 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of bacterial viability		48 hours after the volunteer has started to wear the splints	No
Secondary	thickness in microns		48 hours after the volunteer has started to wear the splints	No