Efficacy of Essential Oil Mouthwash With and Without Alcohol: a 3-Day Plaque Accumulation Model

August 5, 2011 updated by: University of L'Aquila

The daily removal of supragingival dental plaque is a major factor in the prevention of caries, gingivitis and periodontitis. Proper control of bacterial plaque is obtained through the mechanical removal of the biofilm by the proper use of the toothbrush and floss. However, some studies have shown that the mean time of brushing tooth surfaces is less than that required to obtain a proper cleaning 1 and only 2-10% of the patients use dental floss regularly and effectively 2. In addition, it has been demonstrated that even after education and motivation of the patient to the proper use of toothbrush and floss, its compliance is reduced with time 3. The result is the persistence of plaque in some areas, particularly on the interproximal surfaces of teeth. Many studies have demonstrated the effectiveness and usefulness of antiseptic mouthwashes containing active ingredients such as chlorhexidine (CHX) and essential oils (EO) to prevent and control the formation of plaque and gingivitis, when used in addition to mechanical procedures 4-7. Chlorhexidine is still the gold standard for its antimicrobial action and high substantiveness, but side effects, such as pigmentation, taste alteration and the formation of supragingival calculus limit its continued use 8. Essential oil (EO) mouthwashes have been used for years as an adjunct to brushing in addressing oral hygiene. Their effectiveness in controlling plaque and gingivitis are well documented in literature 9-14. They kill microorganisms by destroying their cell walls and inhibiting their enzymatic activity 15,16. Furthermore, phenolic compounds like EOs are known to interfere with the inflammation process 17,18. The antibacterial action is particularly effective for the ability of the mouthwash with EOs to penetrate the biofilm 19-21. The traditional EO mouthwashes contain ethanol, a chemical used to dissolve numerous substances in mouthwashes, including CHX. The concentration of ethanol present in the mouthwash with EOs is more than 20%, sufficient to dissolve the EOs but not enough to carry out a direct antibacterial effect 22,23. Many aspects against the use of alcohol in mouthwashes, such as its effects on the surfaces of composite restorations 24 and its possible role in the formation of oropharyngeal cancer are being discussed 25,26. Although a direct correlation of the cause and effect between the occurrence of oropharyngeal cancer and the use of mouthwashes with alcohol 27, has not demonstrated so far, it is considered desirable to eliminate ethanol for use in daily mouthwash, bringing in search of new formulations. Recently, an EOs containing mouthwash without alcohol was introduced on the European market (Daycare, Curaden, Kriens, and Suisse). To our knowledge, to date there are no published data on the effectiveness of this antimicrobial product. The rinsing with this mouthwash can cause fewer side effects but, in contrast, it may be less effective.

The aim of this study was to evaluate the inhibitory properties of a new alcohol free EO containing mouthwash with respect to the traditional mouthwash containing 21.3% ethanol, through a standard 3-days plaque regrowth model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AQ
      • L'aquila, AQ, Italy, 67100
        • University of L'Aquila, division of periodontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a dentition with ≥20 evaluable teeth (minimum of five teeth per quadrant),
  • no oral lesions
  • no severe periodontal problems (no probing depth ≥5 mm)
  • no removable prostheses or orthodontic bands or appliances

Exclusion Criteria:

  • allergies to several mouthwash components

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: free alcohol essential oil moutwash
Other: free alcohol essential oil mouthwash
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 20 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Active Comparator: alcohol containing essential oil mouthwash
Other: free alcohol essential oil mouthwash
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 20 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference between the two groups using the Plaque Index by Quigley and Hein modified by Turesky
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 5, 2011

First Submitted That Met QC Criteria

August 5, 2011

First Posted (Estimate)

August 8, 2011

Study Record Updates

Last Update Posted (Estimate)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 5, 2011

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/2010/SC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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