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

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

Tracking Information

• First Submitted Date: September 4, 2016
• First Posted Date: September 9, 2016
• Last Update Posted Date: December 15, 2016
• Study Start Date: January 2015
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: September 8, 2016): Dental plaque regrowth [ Time Frame: 3 days ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Alcohol-free Essential Oils Containing Mouthrinse Efficacy on 3-day Supragingival Plaque Regrowth
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Prevention

Condition

• Gingivitis
• Periodontitis

Intervention

• 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

• 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 *

• Marchetti E, Mummolo S, Di Mattia J, Casalena F, Di Martino S, Mattei A, Marzo G. Efficacy of essential oil mouthwash with and without alcohol: a 3-day plaque accumulation model. Trials. 2011 Dec 15;12:262. doi: 10.1186/1745-6215-12-262.
• Marchetti E, Casalena F, Capestro A, Tecco S, Mattei A, Marzo G. Efficacy of two mouthwashes on 3-day supragingival plaque regrowth: a randomized crossover clinical trial. Int J Dent Hyg. 2017 Feb;15(1):73-80. doi: 10.1111/idh.12185. Epub 2015 Nov 2.
• Paraskevas S, Rosema NA, Versteeg P, Van der Velden U, Van der Weijden GA. Chlorine dioxide and chlorhexidine mouthrinses compared in a 3-day plaque accumulation model. J Periodontol. 2008 Aug;79(8):1395-400. doi: 10.1902/jop.2008.070630.
• Charles CA, Amini P, Gallob J, Shang H, McGuire JA, Costa R. Antiplaque and antigingivitis efficacy of an alcohol-free essential-oil containing mouthrinse: a 2-week clinical trial. Am J Dent. 2012 Aug;25(4):195-8.
• Marchetti E, Tecco S, Caterini E, Casalena F, Quinzi V, Mattei A, Marzo G. Alcohol-free essential oils containing mouthrinse efficacy on three-day supragingival plaque regrowth: a randomized crossover clinical trial. Trials. 2017 Mar 31;18(1):154. doi: 10.1186/s13063-017-1901-z.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 8, 2016): 21
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: July 2016
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT02894593
• Other Study ID Numbers: RCT_001_16
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Enrico Marchetti, University of L'Aquila
• Original Responsible Party: Same as current
• Current Study Sponsor: University of L'Aquila
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: GIUSEPPE MARZO, DMD; University of L'Aquila

• PRS Account: University of L'Aquila
• Verification Date: December 2016