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临床试验/NCT07537790
NCT07537790已完成不适用

Comparison of The Effectiveness of Autobrush® Versus Manual Regular Toothbrush Among Adolescents With Fixed Orthodontic Appliances

Shahad Abudawood1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
The main outcome variable is the Full Mouth Plaque Score (FMPS)

研究概览

简要总结

This study is a randomized crossover clinical trial designed to compare the effectiveness of a U-shaped automatic toothbrush (Autobrush®) versus a conventional manual toothbrush in reducing dental plaque among adolescents undergoing fixed orthodontic treatment. Each participant will be exposed to both interventions during the study period due to the crossover design.

The inclusion criteria included healthy adolescents aged 12-15 years, whom were undergoing treatment with fixed orthodontic appliances attending the Orthodontic Department at KAUD Medically compromised adolescents, those with disabilities, individuals without fixed orthodontic appliances, and adolescents with known nylon allergies were excluded.

Before appointment, participants were instructed to refrain from all oral hygiene measures (e.g., brushing, chewing gum) for 12 hours. On the appointment time, at the clinic, participants are assigned randomly to a toothbrush group and given disclosing solution to visualize plaque.

The FMPS was recorded before brushing. Then, participants brush under supervision with their assigned toothbrush group, either manual toothbrush using Bass technique for 2 minutes or using Autobrush® with side-to-side motion for 30 seconds. After brushing, FMPS is reassessed using the same disclosing procedure. Following a washout period of at least 2 weeks, the participant repeats the procedure with the alternative toothbrush.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • The inclusion criteria included healthy adolescents aged 12-15 years, whom were undergoing treatment with fixed orthodontic appliances attending the Orthodontic Department at KAUD

排除标准

  • Medically compromised adolescents, those with disabilities, individuals without fixed orthodontic appliances, and adolescents with known nylon allergies were excluded.

研究组 & 干预措施

Manual regular toothbrush

Experimental

干预措施: U-shaped toothbrush (Autobrush®) (Device)

Manual regular toothbrush

Experimental

干预措施: Manual regular toothbrush (Device)

U-shaped toothbrush (Autobrush®)

Experimental

干预措施: U-shaped toothbrush (Autobrush®) (Device)

U-shaped toothbrush (Autobrush®)

Experimental

干预措施: Manual regular toothbrush (Device)

结局指标

主要结局

The main outcome variable is the Full Mouth Plaque Score (FMPS)

时间窗: 14 days

Plaque levels were recorded on six sites per tooth (three buccal and three lingual), both before and after brushing. The FMPS difference is calculated as: FMPS difference = FMPS before brushing - FMPS after brushing This difference is expressed as a percentage: (Number of sites with plaque / Total number of sites examined) × 100

次要结局

未报告次要终点

研究者

发起方
Shahad Abudawood
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shahad Abudawood

Assistent peofessor

King Abdulaziz University

研究点 (1)

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