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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02946814

Enrollment

Registered

2016-10-27

Start date

2016-10-31

Completion date

Unknown

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biofilms, Substantivity, Oils, Essential

Keywords

essential oils, microscope, colfocal, dental plaque

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.

Interventions

DRUGessential oils

DRUGessential oils without mouthwash

DRUGsterile water

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Percentage of bacterial viability	48 hours after the volunteer has started to wear the splints

Secondary

Measure	Time frame
thickness in microns	48 hours after the volunteer has started to wear the splints

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026