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OpenTrials
Completed

NCT Number: NCT07043517

TMJ Dysfunction and Motor Severity in Children With CP

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

RDC/TMD

Other

TMJ functions were assessed using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).

Primary outcomes

  1. Temporomandibular Joint (TMJ) Functional Status

    Time frame: 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.

Secondary outcomes

  1. Bruxism Prevalence

    Time frame: Single assessment at baseline

    Presence of bruxism identified through parental reports and clinical signs such as tooth wear and nocturnal grinding.

  2. Gross Motor Function Level (GMFCS)

    Time frame: Single assessment at baseline

    Classification of motor function using GMFCS Levels I to IV to explore associations with TMJ dysfunction.

  3. CP Subtype Distribution

    Time frame: Single assessment at baseline

    Classification of CP subtype as spastic, dyskinetic/ataxic, or mixed type to examine subgroup differences in TMJ outcomes.

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Collaborators

  • Kayseri University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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