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Alcohol-free Essential Oils Containing Mouthrinse Efficacy on 3-day Supragingival Plaque Regrowth

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ClinicalTrials.gov Identifier: NCT02894593
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Enrico Marchetti, University of L'Aquila

Brief Summary:
The purpose of this study is to evaluate the antiplaque effects of an alcohol-free essential-oil containing mouthrinse - Listerine Zero (LZ) and an alcohol-based essential oils (EO+) mouthwash compared to a positive control of 0.20% chlorhexidine (CHX) mouthwash, and a negative control of a placebo solution (saline), using an in vivo plaque regrowth model of 3 days.

Condition or disease Intervention/treatment Phase
Gingivitis Periodontitis Other: alcohol free essential oils mouthwash Other: alcohol essential oils mouthwash Other: 0.20% chlorhexidine mouthwash Other: Placebo Not Applicable

Detailed Description:

Plaque is a biofilm of microorganisms responsible for the development of caries and periodontal disease. The daily removal of supragingival dental plaque represents a major factor in the prevention of caries, gingivitis and periodontitis. Plaque control is largely obtained by daily effective tooth brushing and inter-dental cleaning, but in some cases plaque removal can be improved by adding the use of a mouthwash.

An effective action of chemical formulation (especially antiseptics) to control plaque and gingivitis levels has been proved.

Most mouthwashes contain an alcohol (especially ethanol) in order to act as a carrier agent for active essential oils to penetrate the plaque, and to give the subject a "clean mouth sensation".

The alcohol content of mouthwashes, besides having antiseptic properties, serves the purpose of breaking down or dissolving active principles, in addition to that of preserving the formula components, although such content does not directly contribute to effective biofilm and gingivitis control.

However, there are some contraindications in the use of alcohol-based mouthwashes, like the use by infants, pregnant women, alcohol addicts and patients with mucosal injuries. There are also some undesirable effects, like burning or sore sensation, or a painful sensation for patients with existing soft tissue injuries, or a perception of dryness in the mouth.

In order to avoid the use of alcohol-based mouthwashes in particular conditions, scientific interest is becoming more widespread in introducing a mouthrinse with strong anti-plaque qualities and no alcoholic ingredients.

One of these product is the alcohol-free essential oil mouthwash Listerine Zero (LZ), that has little documentation with regard to its anti-plaque effects.

The aim of this study was to evaluate the antiplaque effects of an alcohol-free essential oil mouthwash (Listerine Zero, LZ) and a alcohol-based essential oil mouthwash (EO+), compared to a positive control of a 0.2% chlorhexidine mouthwash (CHX), and a negative control of a placebo solution (saline), using an in vivo plaque regrowth model of 3 days.

The study was designed as a double-masked, randomized, crossover clinical trial, involving 21 volunteers to compare four different mouthwashes, using a 3-day plaque regrowth model. After receiving thorough professional prophylaxis at baseline, over the next 3 days, each volunteer refrained from all oral hygiene measures and performed two daily rinses with 15 ml of the test mouthwashes. EO+ was compared to LZ. CHX rinse served as a positive control, and a placebo solution as a negative control. At the end of each experimental period, plaque index (PI) was assessed, and a panelists completed through a visual analogue scale (VAS) questionnaire evaluating the organoleptic properties of each product. Each subject underwent a 14-day washout period, and then there was another allocation.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Alcohol-free Essential Oils Containing Mouthrinse Efficacy on 3-day Supragingival Plaque Regrowth: a Randomized Crossover Clinical Trial
Study Start Date : January 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : July 2016

Arm Intervention/treatment
alcohol essential oils mouthwash
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Other: alcohol essential oils mouthwash
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Other Name: Listerine, Johnson & Johnson Consumer Inc.

Active Comparator: 0.20% chlorhexidine mouthwash
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Other: 0.20% chlorhexidine mouthwash
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Other Name: Meridol Chlorhexidine 0.20, GABA International AG

Placebo Comparator: Placebo
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Other: Placebo
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.

Experimental: alcohol free essential oils mouthwash
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Other: alcohol free essential oils mouthwash
All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
Other Name: Listerine Zero, Johnson & Johnson Consumer Inc.




Primary Outcome Measures :
  1. Dental plaque regrowth by clinical plaque index [ Time Frame: 3 days ]
    all of the volunteers were examined with an erythrosine solution, and the plaque in both groups was recorded at six sites per tooth using the Quigley and Hein index , as modified by Turesky et al. and further modified by Lobene et al.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • dentition with ≥ 20 evaluable teeth (minimum of five teeth per quadrant)
  • age between 20 and 50 years old

Exclusion Criteria:

  • oral lesions
  • severe periodontal problems (probing depth ≥5 mm or attachment loss >2 mm)
  • removable prostheses or orthodontic bands/ or appliances
  • Subjects allergic to several mouthrinse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894593


Locations
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Italy
University of L'Aquila, Division of Periodontology
L'aquila, AQ, Italy, 67100
Sponsors and Collaborators
University of L'Aquila
Investigators
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Study Chair: GIUSEPPE MARZO, DMD University of L'Aquila

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Enrico Marchetti, Adjunct Professor, University of L'Aquila
ClinicalTrials.gov Identifier: NCT02894593     History of Changes
Other Study ID Numbers: RCT_001_16
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Periodontitis
Gingivitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Pharmaceutical Solutions
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Listerine
Sodium Fluoride
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants
Dermatologic Agents
Cariostatic Agents
Protective Agents