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临床试验/NCT05212415
NCT05212415已完成不适用

Reported Bruxism and Parafunctional Oral Habits in Children and Adolescents With Spastic Cerebral Palsy: a Cross-sectional Study

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Water Swallowing Test (WST)

研究概览

简要总结

The aim of the study is to evaluate and analyze the rates and relationships between bruxism, other parafunctional oral activities, and oral-motor activities in children and adolescents with spastic CP.

详细描述

This cross-sectional study was conducted on children and adolescents with CP receiving care services in three different private rehabilitation centers between January 2020 and March 2021. All the parents or primary caregivers included in the study were mothers of children with CP. Initially, information about bruxism and parafunctional oral habits and the study's aims were given to the mothers. All the mothers provided written informed consent for voluntary participation.

63 children and adolescents with spastic CP were analyzed, comprising 35 girls and 28 boys.

All the children were observed in clinical environments for classification according to the Gross Motor Function Classification System (GMFCS) and levels of activity and communication.

Data were collected from an evaluation form, clinical examination of the individuals, and interviews with the mothers.

In the first section of the evaluation, the medical records of the children with CP were reviewed for demographics, and clinical data, including age, gender, CP type, medication, and history of epilepsy. The GMFCS was used to determine the level of impairment in gross motor functions of the children.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents with a diagnosis of spastic CP.
  • Children and adolescents ages between 3-18 years old.

排除标准

  • Children and adolescents with a diagnosis of dyskinetic, ataxic, and/or mixed type CP
  • were aged <3 years or ≥19 years,
  • had severe sight or hearing impairment, or had received any orthodontic treatment

结局指标

主要结局

Water Swallowing Test (WST)

时间窗: January 2020 and March 2021

In this WST, the subjects in the study were seated and instructed to drink 10 ml of room temperature water. The time taken to drink all the water was recorded. Delayed swallow initiation, drooling, coughing, throat clearing, or a change in voice quality may indicate a problem. After the swallow, the patient should be observed for a minute or more to see a delayed cough response. According to the test evaluation criteria, a score of 1=normal swallowing ability, 2=a likelihood of reduced swallowing ability, and 3= reduced swallowing ability.

The GMFCS level

时间窗: January 2020 and March 2021

The GMFCS is a widely used, valid, and reliable, standardized system that classifies the impairment of gross motor functions of children with CP in 5 levels (I-II: mild; III: moderate; and IV-V: severe) based on the disabilities and level of dependence.

Parental reported Bruxism

时间窗: January 2020 and March 2021

The mothers of the children in the study were given information about bruxism and parafunctional habits. They were then asked, "During the past six months, have you noticed noises of your child clenching or grinding their teeth either when awake or at least three nights a week when sleeping?". The responses were recorded as parental-reported bruxism present or absent.

The Tongue Thrust Rating Scale (TTRS)

时间窗: January 2020 and March 2021

The TTRS scale evaluates the tongue's position inside the mouth in four different locations. Tongue position is expressed in figures from 0 to 3, where 0 = none (the tongue is not outside the mouth), 1=mild (tongue between the teeth), 2= moderate (tongue between the lips), and 3= severe (tongue outside the mouth).

Drooling Severity and Frequency Scale

时间窗: January 2020 and March 2021

The DSFS, developed by Thomas-Stonell and Greenberg in 1988, is used to determine the level of the saliva control problem. 23 According to the information from the mothers and observation findings, drooling severity was scored from 1-5 and drooling frequency from 1-4. The severity points are interpreted as 1 = no drooling, dry lips, 2=mild, 3= moderate, 4= severe, and 5= excessive drooling wetting the clothes. The frequency points are interpreted as 1=never, 2= occasionally, 3= often, and 4=continuously.

次要结局

未报告次要终点

研究者

发起方
Hasan Kalyoncu University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysenur Tuncer

PT, PhD

Hasan Kalyoncu University

研究点 (1)

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