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临床试验/NCT07043517
NCT07043517已完成不适用

TEMPOROMANDIBULAR JOINT DYSFUNCTION IN CHILDREN WITH CEREBRAL PALSY: ASSOCIATIONS WITH GMFCS LEVELS, SUBTYPES, AND BRUXISM

Istanbul Arel University1 个研究点 分布在 1 个国家目标入组 517 人开始时间: 2023年7月30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
517
试验地点
1
主要终点
Temporomandibular Joint (TMJ) Functional Status

研究概览

简要总结

This study aims to examine the function of the temporomandibular joint (TMJ)-the jaw joint-in children with cerebral palsy (CP). Children with CP often experience difficulties in jaw movement, pain, or involuntary grinding of teeth (bruxism), which can affect their ability to eat, speak, or smile comfortably.

The research will investigate how the severity of motor impairment, as classified by the Gross Motor Function Classification System (GMFCS), and different CP subtypes are related to jaw function problems. The study also explores the relationship between bruxism and TMJ pain and dysfunction.

By performing clinical evaluations of mouth opening, jaw movements, muscle tenderness, and pain levels, this study hopes to identify early signs of TMJ problems. The goal is to provide better recommendations for early screening, therapy, and rehabilitation for children with CP, especially those with more severe motor impairments.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Diagnosed with cerebral palsy (CP) by a pediatric neurologist, based on standard clinical criteria.
  • Aged between 6 and 18 years.
  • Classified as GMFCS Levels I to IV.
  • Able to comply with clinical assessment procedures.
  • Written informed consent obtained from parent(s) or legal guardian(s). Exclusion Criteria
  • GMFCS Level V (due to inability to cooperate with TMJ examination).
  • History of craniofacial trauma, surgery, or congenital maxillofacial anomalies.
  • Presence of neuromuscular diseases other than cerebral palsy.
  • Active temporomandibular joint infection or acute systemic illness at the time of evaluation.
  • Ongoing use of muscle relaxants or botulinum toxin injections in the jaw region within the past 6 months.
  • Inability to complete the TMJ clinical examination due to behavioral or cognitive limitations.

排除标准

  • 未提供

结局指标

主要结局

Temporomandibular Joint (TMJ) Functional Status

时间窗: Single assessment at baseline

Evaluation of TMJ functions using maximum mouth opening (mm), lateral jaw movement (mm), presence of joint sounds (click/crepitus), palpation tenderness, and Visual Analog Scale (VAS) for pain.

次要结局

  • Bruxism Prevalence(Single assessment at baseline)
  • Gross Motor Function Level (GMFCS)(Single assessment at baseline)
  • CP Subtype Distribution(Single assessment at baseline)

研究者

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

Ozge Baykan Copuroglu

Asst. Prof.

Istanbul Arel University

研究点 (1)

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