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临床试验/NCT03841825
NCT03841825已完成不适用

Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients: a Randomized Clinical Trial

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2019年2月1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
67
试验地点
2
主要终点
Change in 3-item Bleeding Index (BI)

研究概览

简要总结

This study will compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements.

详细描述

Orthodontic treatment (i.e. braces) makes it hard to keep good oral hygiene. The purpose of this research study is to compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements. Participation in this study will last up to 6 months and will consist of 4 study visits to the VCU Orthodontic clinic which are also regular visits for treatment. Measurements to assess participant's oral health will be taken during these visits. Participants will be randomly assigned to 1 of 4 groups which may include receiving different types of text messages, repeated in-person oral hygiene instructions, or both, or neither.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
11 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 11-20 that have their own mobile device
  • Patients have cellular plan that allows them to receive text messages at no extra cost
  • Patients that will undergo treatment with full fixed appliances

排除标准

  • patients with significant medical or dental history, including patients with bleeding disorders that would require antibiotic prophylaxis
  • Pregnant women

结局指标

主要结局

Change in 3-item Bleeding Index (BI)

时间窗: 8 - 12 weeks to 12 - 18 weeks

Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding

次要结局

  • Change in 5-item Modified Gingival Index (MGI)(8 - 12 weeks to 12 - 18 weeks)
  • Change in 6 item Plaque index (PI)(8 - 12 weeks to 12 - 18 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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