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临床试验/NCT06098976
NCT06098976已完成不适用

Dental Plaque Removal Around Orthodontic Braces in Adolescents by Water Jet Device Versus Manual Toothbrush: A Randomized Controlled Trial

Damascus University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in Orthodontic Plaque Index

研究概览

简要总结

The aim of this study was to evaluate the effectiveness of the water jet in removing dental plaque around the orthodontic braces in adolescents.

详细描述

The aim of this randomized controlled trial was to evaluate the effectiveness of the water jet in removing dental plaque around the orthodontic braces compared to manual toothbrush in adolescents. The null hypothesis was that no significant difference would be noted between the Water Jet and manual toothbrush in removing dental plaque around the orthodontic braces. Such studies provide another dental care tools for maintaining oral hygiene among orthodontic patients.

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 (Participant, Investigator)

入排标准

年龄范围
11 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children.
  • Children aged 11 to 15 years.
  • Children who did not receive any fluoride treatment in the dental clinic.
  • Patients who had orthodontic braces at least on the anterior segment of the upper and lower jaws.

排除标准

  • Special Health Care Needs (SHCN) patients.

结局指标

主要结局

Change in Orthodontic Plaque Index

时间窗: First assessment time: one day before the commencement of the trial. Second assessment time: four months after the commencement of orthodontic treatment

The plaque accumulation is measured using the Orthodontic Plaque Index (OPI) Dental plaque is going to be disclosed using a disclosing solution (Mira-2-Ton®, Hager \& Werken GmbH \& Co. KG, Duisburg, Germany) after the last brushing then immediately after cleansing. The dentition is divided into sextants, and the highest score of plaque accumulation per sextant is going to be assigned. The OPI for a patient was determined by calculating the average.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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