NCT07043517

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
517

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 21, 2025

Last Update Submit

June 21, 2025

Conditions

Keywords

cerebral palsytemporomandibular jointGMFCS

Outcome Measures

Primary Outcomes (1)

  • Temporomandibular Joint (TMJ) Functional Status

    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.

    Single assessment at baseline

Secondary Outcomes (3)

  • Bruxism Prevalence

    Single assessment at baseline

  • Gross Motor Function Level (GMFCS)

    Single assessment at baseline

  • CP Subtype Distribution

    Single assessment at baseline

Study Arms (1)

Cerebral palsy

GMFCS Level 1-4

Other: RDC/TMD

Interventions

RDC/TMDOTHER

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

Cerebral palsy

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of children and adolescents aged 6 to 18 years who have been clinically diagnosed with cerebral palsy (CP) and classified within Gross Motor Function Classification System (GMFCS) Levels I to IV. Participants will be recruited from pediatric neurology and physical therapy outpatient clinics of tertiary hospitals. The population is expected to represent a diverse range of CP subtypes (spastic, dyskinetic/ataxic, and mixed) and levels of functional motor impairment, allowing for subgroup analysis in relation to temporomandibular joint (TMJ) function. Participants must be able to comply with basic oral-motor assessments and have obtained informed consent from their parent(s) or legal guardian(s).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri University

Kayseri, Kayseri, 38130, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral PalsyTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

June 21, 2025

First Posted

June 29, 2025

Study Start

July 30, 2023

Primary Completion

January 30, 2024

Study Completion

July 30, 2024

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations