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临床试验/NCT03119441
NCT03119441Unknown不适用

The Efficacy of Dental Water Jet in Plaque Removal During Orthodontic Treatment With Fixed Appliances: A Randomized Controlled Trial

Riyadh Colleges of Dentistry and Pharmacy2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年12月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Change in plaque index

研究概览

简要总结

The aim of this study is to assess the efficacy of dental water jet in plaque removal and gingival health during orthodontic treatment with fixed appliances.

详细描述

Subjects will be randomized into two groups. The first group will receive a dental water jet and the second group will receive dental floss. Plaque accumulation using plaque index and gingival health using gingival index will be measured at baseline and after four weeks for each group and then, results will be compared.

研究设计

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

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects having orthodontic fixed appliance.
  • Subjects aged 12 years old and above who own mobile phones and no mental or physical disabilities.
  • Subjects willing to comply with given oral hygiene instructions.

排除标准

  • 未提供

研究组 & 干预措施

Dental water jet

Experimental

Dental water jet (Jetpik JP210)

干预措施: Dental Water Jet (Device)

Dental floss

Active Comparator

Dental floss

干预措施: Dental Floss (Device)

结局指标

主要结局

Change in plaque index

时间窗: At baseline and after 4 weeks.

Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.

Change in gingival index

时间窗: At baseline and after 4 weeks.

Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.

次要结局

未报告次要终点

研究者

发起方
Riyadh Colleges of Dentistry and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Omar Alkadhi

Assistant professor

Riyadh Colleges of Dentistry and Pharmacy

研究点 (2)

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