跳至主要内容
临床试验/NCT03601585
NCT03601585已完成早期 1 期

Evaluation of the Effectiveness of Fibrous Foods, Sugar-free Gomes and Rolly Brush® in the Dental Biofilm Removal: A Randomized, Double Masked Clinical Trial

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月15日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Plaque index

研究概览

简要总结

The objective of this study was to evaluate the efficacy of three methods for removal of dental biofilm when compared to dental toothbrushing control. Twenty patients were diagnosed and randomized into four groups according to the method tested: 1) apple 2) Rolly Brush 3) chewing gum and 4) brushing control. Subjects were evaluated four times according to the method used. All were evaluated before performing any method and after using each of the four methods separately. The patient's evaluation interval was 24 hours between the use of the methods. In the first stage, they underwent a clinical examination in which the needs of supragingival scraping or definitive restorations and prophylaxis were detected. After this step, all methods of oral hygiene and the consumption of fibrous foods and chewing gum were suspended for twenty-four hours. In the second stage, with a minimum of twenty-four hours after the first, volunteers received approximately 10 ml of basic fucsin to perform a mouthwash. The dental examination was then carried out for measurement on each dental surface and the plaque index was recorded on each surface. In the latter, four evaluations were performed with at least a 24-hour interval until the patients used the four methods

研究设计

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

入排标准

年龄范围
18 Years 至 26 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Good periodontal health
  • •Minimum of eight occlusal surfaces of premolars and molars hygienic

排除标准

  • •Less than eight occlusal surfaces
  • •Use of orthodontic appliance
  • •Use of dental prosthesis

研究组 & 干预措施

Rolly Brush

Experimental

Chew for 1 minute

干预措施: Comparison of dental biofilm removal. (Device)

Chewing gum

Experimental

Chew for 1 minute

干预措施: Comparison of dental biofilm removal. (Device)

Apple

Experimental

Chew for 1 minute

干预措施: Comparison of dental biofilm removal. (Device)

Brush

Active Comparator

brush for 1 minute

干预措施: Comparison of dental biofilm removal. (Device)

结局指标

主要结局

Plaque index

时间窗: 3 months

Comparison of the Quigley-Hein plaque index between the following groups: rolly brush, chewing gum, a, apple, brush.

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olga Flecha

Principal Investigator

Federal University of São Paulo

研究点 (1)

Loading locations...

相似试验