临床试验/NCT02267239

NCT02267239Unknown4 期

Methodology of Application and Immediate Effect of the Essential Oils and 0.2% Chlorhexidine on Oral Biofilm: Immersion Versus Mouthwash.

University of Santiago de Compostela1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2014年10月最近更新: 2014年10月23日

适应症

干预措施

试验速览

阶段: 4 期
发起方: University of Santiago de Compostela
入组人数: 15
试验地点: 1
主要终点: change in bacterial vitality

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study has the objective to compare two different methodology of application the antiseptic on the oral biofilm will be formed during 48h in situ on a specific device. The first one using the immersion in the antiseptic solution, as much of the authors did in the past. And the second way doing a active mouthwash, as the manufacturer recommends.

The study will compare two different antiseptic solutions, the chlorhexidine (0.2% Oraldine Perio) and the essential oils (Listerine Mentol) with the two different application and compared the bacterial vitality, thickness and covering grade between solutions and with a basal sample.

详细描述

15 healthy volunteers, between 20 and 45 years old, will use during 48 hours two specific oral devices with 3 glass disks each. After this period, one of the disk will be drawn from the device and it will be immersed in Live/Dead BacLight solution for 15 minutes and then the disk will be analysed by the Confocal Laser Scanning Microscope (CLSM). Immediately, another disk will be removed from the intraoral device and immersed in the antiseptic solution, being analysed by the CLSM as well. After that, the volunteers will do the mouthwash with the antiseptic solution (as stated in the specific protocol) and the last disk will be drawn from the device and will be analysed by the CLSM following the same protocol. The other 3 disk will undergo the same protocol of baseline, immersion and mouthwash, but with the other antiseptic solution.

The CLSM data will be analysed and the bacterial vitality, thickness and covering grade will be calculated. Finally the statistical analysis will be applied (Pairwise comparisons, with the Bonferroni adjustment).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: Double (Investigator, Outcomes Assessor)

入排标准

年龄范围: 20 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•good oral health status: a minimum of 24 permanent teeth with no evidence of gingivitis or periodontitis and absence of untreated caries

排除标准

•smoker or former smoker
•presence of dental prostheses or orthodontic devices
•antibiotic treatment or routine use of oral antiseptics in the previous three months
•presence of any systemic disease that could alter the production or composition of saliva

研究组 & 干预措施

Essential Oils, immersion

Active Comparator

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution

干预措施: essential oils, immersion (Drug)

Essential Oils, immersion

Active Comparator

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution

干预措施: professional oral cleaning (Procedure)

Essential Oils, immersion

Active Comparator

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution

干预措施: Plaster cast (Procedure)

Essential Oils, immersion

Active Comparator

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the essential oils antiseptic solution

干预措施: IDODS (Device)

Chlorhexidine, immersion

Active Comparator

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution

干预措施: Chlorhexidine, immersion (Drug)

Chlorhexidine, immersion

Active Comparator

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution

干预措施: professional oral cleaning (Procedure)

Chlorhexidine, immersion

Active Comparator

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution

干预措施: Plaster cast (Procedure)

Chlorhexidine, immersion

Active Comparator

Professional oral cleaning Plaster cast IDODS Immersion the disk with the biofilm in the chlorhexidine antiseptic solution

干预措施: IDODS (Device)

baseline

Other

Professional oral cleaning Plaster cast IDODS Disk in basal conditions.

干预措施: professional oral cleaning (Procedure)

baseline

Other

Professional oral cleaning Plaster cast IDODS Disk in basal conditions.

干预措施: Plaster cast (Procedure)

baseline

Other

Professional oral cleaning Plaster cast IDODS Disk in basal conditions.

干预措施: IDODS (Device)

Essential Oils, mouthwash

Active Comparator

Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution

干预措施: essential oils, mouthwash (Drug)

Essential Oils, mouthwash

Active Comparator

Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution

干预措施: professional oral cleaning (Procedure)

Essential Oils, mouthwash

Active Comparator

Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution

干预措施: Plaster cast (Procedure)

Essential Oils, mouthwash

Active Comparator

Professional oral cleaning Plaster cast IDODS Active mouthwash with the essential oils antiseptic solution

干预措施: IDODS (Device)

Chlorhexidine, mouthwash

Active Comparator

Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution

干预措施: chlorhexidine, mouthwash (Drug)

Chlorhexidine, mouthwash

Active Comparator

Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution

干预措施: professional oral cleaning (Procedure)

Chlorhexidine, mouthwash

Active Comparator

Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution

干预措施: Plaster cast (Procedure)

Chlorhexidine, mouthwash

Active Comparator

Professional oral cleaning Plaster cast IDODS Active mouthwash with the chlorhexidine antiseptic solution

干预措施: IDODS (Device)

结局指标

主要结局

change in bacterial vitality

时间窗: baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)

percentage of live bacteria in the sample

change in thickness

时间窗: baseline, 30 seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)

maximum numbers of layers (1micra per layer) with continuous presence of bacteria

change in covering grade

时间窗: baseline, 30seconds after immersion and 30 seconds after mouthwash (in both antiseptic solutions)

percentage of the disk surface occupied by the biofilm

次要结局

未报告次要终点

研究者

发起方

University of Santiago de Compostela

申办方类型

Other

责任方

Principal Investigator

主要研究者

Inmaculada Tomas

Senior lecturer

University of Santiago de Compostela

研究点 (1)

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