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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

Tracking Information
First Submitted Date  ICMJE September 4, 2016
First Posted Date  ICMJE September 9, 2016
Last Update Posted Date December 15, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2016)
Dental plaque regrowth [ Time Frame: 3 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alcohol-free Essential Oils Containing Mouthrinse Efficacy on 3-day Supragingival Plaque Regrowth
Official Title  ICMJE Alcohol-free Essential Oils Containing Mouthrinse Efficacy on 3-day Supragingival Plaque Regrowth: a Randomized Crossover Clinical Trial
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Gingivitis
  • Periodontitis
Intervention  ICMJE
  • 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.
  • 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.
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: alcohol essential oils mouthwash
  • 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.
    Intervention: Other: 0.20% chlorhexidine mouthwash
  • 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.
    Intervention: Other: Placebo
  • 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.
    Intervention: Other: alcohol free essential oils mouthwash
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2016)
21
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02894593
Other Study ID Numbers  ICMJE RCT_001_16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Enrico Marchetti, University of L'Aquila
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of L'Aquila
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: GIUSEPPE MARZO, DMD University of L'Aquila
PRS Account University of L'Aquila
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP