Cerebral PalsyNCT07043517
TMJ Dysfunction and Motor Severity in Children With CP
An observational study of Cerebral Palsy and Temporomandibular Disorder (TMD), run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Temporomandibular Disorder (TMD)
- What is being tested?
- RDC/TMD
- How many people
- 517 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2023to 30 Jul 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- 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).
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TEMPOROMANDIBULAR JOINT DYSFUNCTION IN CHILDREN WITH CEREBRAL PALSY: ASSOCIATIONS WITH GMFCS LEVELS, SUBTYPES, AND BRUXISM
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.
- Conditions
- Cerebral Palsy, Temporomandibular Disorder (TMD)
- Being tested
- RDC/TMD
- Keywords
- cerebral palsy, temporomandibular joint, GMFCS
- Medical subject headings
- Cerebral Palsy, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDC/TMDOther
TMJ functions were assessed using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
| Study group | Role | What they receive |
|---|---|---|
| Cerebral palsy | GMFCS Level 1-4 Receives: Other: RDC/TMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single assessment at baseline
Secondary outcomes (3)
Bruxism Prevalence
Presence of bruxism identified through parental reports and clinical signs such as tooth wear and nocturnal grinding.
Measured: Single assessment at baseline
Gross Motor Function Level (GMFCS)
Classification of motor function using GMFCS Levels I to IV to explore associations with TMJ dysfunction.
Measured: Single assessment at baseline
CP Subtype Distribution
Classification of CP subtype as spastic, dyskinetic/ataxic, or mixed type to examine subgroup differences in TMJ outcomes.
Measured: Single assessment at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start30 Jul 2023
- Primary completion30 Jan 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 517 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Collaborators
- Kayseri University
- Responsible party
- Principal investigator, Ozge Baykan Copuroglu, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043517
- Sponsor's protocol ID
- TMDCPPrevalance
- Other IDs
- YOK-Tez-ID:896940
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEMPOROMANDIBULAR JOINT DYSFUNCTION IN CHILDREN WITH CEREBRAL PALSY: ASSOCIATIONS WITH GMFCS LEVELS, SUBTYPES, AND BRUXISM
- ClinicalTrials.gov ID
- NCT07043517
- Acronym / sponsor ID
- TMDCPPrevalance
- Conditions
- Cerebral Palsy, Temporomandibular Disorder (TMD)
- Keywords
- cerebral palsy, temporomandibular joint, GMFCS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Collaborators
- Kayseri University
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cerebral palsy | – | Other: RDC/TMDGMFCS Level 1-4 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDC/TMDTMJ functions were assessed using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). | Other | Cerebral palsy |
Primary outcome
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.
3 secondary outcomes
Bruxism Prevalence
Time frame: Single assessment at baseline
Gross Motor Function Level (GMFCS)
Time frame: Single assessment at baseline
CP Subtype Distribution
Time frame: Single assessment at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Temporomandibular Disorder (TMD), run by Istanbul Arel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporomandibular Joint (TMJ) Functional Status (time frame: Single assessment at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.