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临床试验/NCT04075617
NCT04075617已完成不适用

Cessation of Thumb/Finger Sucking Habit in Children Using Electronic Habit Reminder Versus Palatal Crib.Randomized Clinical Pilot Study.

Cairo University2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年12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
22
试验地点
2
主要终点
Cessation of thumb/finger sucking habit

研究概览

简要总结

The aim of this study is to assess the use of electronic habit reminder and palatal crib in the cessation of thumb/finger sucking habit.

Treatment of thumb/finger sucking by extraoral approaches are well accepted by school-age children (Adair, 1999). It was reported in a case study by Krishnappa et al that the use of an extraoral electronic habit reminder is a new method used for cessation of thumb/finger sucking habit in short time and it is more comfortable and acceptable to the child (Krishnappa et al, 2016).

详细描述

This study will be conducted in, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University. Diagnosis and patient selection will be at outpatient clinic in the specific days of diagnosis. Impression taking, delivery of appliances and follow up will be at post graduate clinic under supervision of the main and assistant supervisor.

Eligible patients will be randomized to form two groups, Intervention group: Treatment by using electronic habit reminder which will be constructed by taking impression for the thumb/finger using silicon impression material (putty consistency) and pouring it with dental stone. The replica of the finger is used to formulate a custom made cover for it, which consists of stainless steel wires with specific design and acrylic resin this is the first part of the reminder. The second part is in the shape of wrist watch which is connected to the first part by a wire. When the child puts his finger in his mouth the stainless steel wires touch each other and the watch produces alarming sound and counts how many times the alarm goes off. The child should wear the appliance most of the time except during eating and activities.

Control group: Treatment by using palatal crib which will be constructed by taking impression for upper arch with alginate impression material, and then will be sent to the lab for fabrication. Cementation of the appliance and then follow up.

Follow up will be at two weeks and 1, 3, 6 months.

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
None

盲法说明

Blinding isn't feasible except for the statistician.

入排标准

性别
All
接受健康志愿者

入选标准

  • Children with thumb/finger sucking habit.
  • After eruption of upper first permanent molar
  • open bite

排除标准

  • Patients with special health care need
  • Uncooperative child
  • Parents refuse the participation of their child

结局指标

主要结局

Cessation of thumb/finger sucking habit

时间窗: 6 monthes

cessation of thumb/finger sucking habit is by asking the parent in every appointment during the follow up period if the notice that their child has stopped the habit or at least there is decrease in the duration

次要结局

  • parental acceptance(6 monthes)
  • child acceptance(6 monthes)
  • time for habit cessation(6 monthes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tassneim Ahmed

B.D.S, Faculty of Dentistry

Cairo University

研究点 (2)

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