Antiplaque Effect of Essential Oils With and Without Alcochol on an in Situ Model of Oral Biofilm Growth

Periodontitis Clinical Trial

Official title:

Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth. A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02946801
• Other study ID #: 395/2016
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 21, 2016
• Last updated: October 26, 2016
• Start date: November 2016
• Est. completion date: December 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

The accumulation and maturation of oral biofilm in the gingival margin is widely recognised to be the primary aetiological factor in the development of chronic gingivitis. Based on this association, the current treatment of gingivitis is focused on biofilm disruption, which will normally include mechanical processes, both professionally and at home. However, for patients, it is not easy to achieve a proper level of plaque control. The efficient plaque control techniques are very time consuming and require a special motivation and skills for their optimum use. It was at this point where mouthwashes become important, due to the fact that they include diverse types of antimicrobial agents to complement the results of mechanical oral hygiene measures.

The essential oils have been presented as a realiable alternative to the "gold Standard" (Chlorhexidine). However, it use has been limited clinically due to their alcohol contain. Some years ago, a new alternative without alcohol has been launched to the market. This formulation has not been already deeply tested specific antiplaque studies in which the structure of the biofilm remained intact.

The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (based on an essential oils formulation with and without alcohol) in the short term with a posterior analysis on "non-destructured" biofilm with Confocal Laser Scanning Microscope combined with fluorescence staining.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2016
• 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, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Biofilms
• Oils, Essential
• Periodontitis

Intervention

Drug:
• Essential oils

• Essential oils without alcohol

• 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, Donos N, Suárez-Quintanilla D, Tomás I. Antiplaque effect of essential oils and 0.2% chlorhexidine on an in situ model of oral biofilm growth: a randomised clinical trial. PLoS One. 2015 Feb 17;10(2):e0117177. doi: 10.1371/journal.pone.0117177. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of bacterial viability		96 hours after the volunteer has worn the splints with the disks	No
Secondary	Thickness in microns		96 hours after the volunteer has worn the splints with the disks	No
Secondary	Percentage of area covered by the biofilm		96 hours after the volunteer has worn the splints with the disks	No