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临床试验/NCT02894593
NCT02894593已完成不适用

Alcohol-free Essential Oils Containing Mouthrinse Efficacy on 3-day Supragingival Plaque Regrowth: a Randomized Crossover Clinical Trial

University of L'Aquila1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Dental plaque regrowth by clinical plaque index

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

alcohol essential oils mouthwash

Other

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.

干预措施: alcohol essential oils mouthwash (Other)

0.20% chlorhexidine mouthwash

Active Comparator

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.

干预措施: 0.20% chlorhexidine mouthwash (Other)

Placebo

Placebo Comparator

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.

干预措施: Placebo (Other)

alcohol free essential oils mouthwash

Experimental

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.

干预措施: alcohol free essential oils mouthwash (Other)

结局指标

主要结局

Dental plaque regrowth by clinical plaque index

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Enrico Marchetti

Adjunct Professor

University of L'Aquila

研究点 (1)

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