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

This study has been completed.
Sponsor:
Information provided by:
University of L'Aquila
ClinicalTrials.gov Identifier:
NCT01411618
First received: August 5, 2011
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Gingivitis
Periodontitis
Other: free alcohol essential oil mouthwash

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy of Essential Oil Mouthwash With and Without Alcohol: a 3-Day Plaque Accumulation Model

Resource links provided by NLM:


Further study details as provided by University of L'Aquila:

Primary Outcome Measures:
  • difference between the two groups using the Plaque Index by Quigley and Hein modified by Turesky [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411618

Locations
Italy
University of L'Aquila, Division of Periodontology
L'aquila, AQ, Italy, 67100
Sponsors and Collaborators
University of L'Aquila
  More Information

No publications provided by University of L'Aquila

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ENRICO MARCHETTI, University of L'Aquila
ClinicalTrials.gov Identifier: NCT01411618     History of Changes
Other Study ID Numbers: 11/2010/SC
Study First Received: August 5, 2011
Last Updated: August 5, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of L'Aquila:
Antiplaque agents
chemical plaque control
oral hygiene
essential oils
alcohol
mouthwash

Additional relevant MeSH terms:
Gingivitis
Periodontitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014