NCT02124655

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

Completed Phase 4 Last updated 26 April 2014

What this trial tests

Phase 4 trial testing Essential oils in Oral Biofilm in 15 participants. Completed.

Timeline

1 September 2012

Primary endpoint
1 June 2013

Quick facts

Lead sponsor	University of Santiago de Compostela
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	15
Start date	1 September 2012
Primary completion	1 June 2013
Sites	1 location across Spain

Drugs / interventions tested

• Essential oils — full drug profile →
• 0.2% chlorhexidine — full drug profile →
• Sterile water (Sterile Water For Injection) — full drug profile →

Conditions studied

• Oral Biofilm — all drugs for Oral Biofilm →
• Mouthwash — all drugs for Mouthwash →
• Periodontitis — all drugs for Periodontitis →

Sponsor

University of Santiago de Compostela

Who can join

Adults 20 to 45, any sex, with Oral Biofilm or Mouthwash. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Bacterial vitality (%)
  Time frame: 10 hours after the last mouthwash
  ratio of alive/dead bacteria.
• Biofilm thickness (microns)
  Time frame: 10 hours after the last mouthwash
  thickness of the biofilm from the base of the substrate to the top surface of the biofilm
• covering grade (%)
  Time frame: 10 hours after the last mouthwash
  area of the substrate that is covered by the biofilm after the 4 days of treatment

Sponsor's own description

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.

Chlorhexidine is considered the "gold standard" of oral antiseptics; nevertheless it has not been recommended for long periods of time due to its well-known secondary effects. All of these inconveniences have limited its acceptability among dental professionals and users; in contrast, however, are the exceptional antiseptic properties, promoting the interest of researchers in other alternative antiplaque agents. Mouthwashes containing essential oils in their formulation have received a lot of attention. Their antiplaque activity has been demonstrated in numerous clinical studies, in which they were used in conjunction with mechanical oral hygiene measures.

In order to achieve a better understanding of the clinical effects that antimicrobial agents produce in the interior of the biofilm, it is necessary to apply a methodology in which the biofilm grows directly in the interior of the oral cavity but its three dimensional structure is not distorted by manipulation.

The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (essential oils formulation and 0.2% chlorhexidine) in the short term with a posterior analysis on "non-destructured" biofilm with Confocal Laser Scanning Microscope combined with fluorescence staining.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antiplaque effect of essential oils and 0.2% chlorhexidine on an in situ model of oral biofilm growth: a randomised clinical trial.
   Quintas V, Prada-López I, Donos N, Suárez-Quintanilla D, et al · · 2015 · cited 22× · PMID 25689859 · DOI 10.1371/journal.pone.0117177