NCT05572541

Brief Summary

Trauma, neurological disorders and psychological problems, which are the etiological factors of temporomandibular joint dysfunction, can be seen in patients with traumatic brain injury. The aim of this study is to investigate temporomandibular joint dysfunction in patients with traumatic brain injury. Participants (traumatic brain injury patients and healthy volunteers) will be evaluated once for temporomandibular joint dysfunction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 4, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

November 5, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

October 4, 2022

Last Update Submit

October 25, 2022

Conditions

Keywords

Temporomandibular Dysfunction,traumatic brain injuryheadache

Outcome Measures

Primary Outcomes (1)

  • Frequency of temporomandibular joint dysfunction in patients with traumatic brain injury

    01.11.2022

Study Arms (2)

Patients with traumatic brain injury

Temporomandibular joint range of motion, Fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both TBI patients and healthy individuals. In addition, post-injury dietary intake and dominant chewing side will be questioned in TBI patients. Temporomandibular movements will be measured with a disposable cardboard ruler.

Diagnostic Test: Fonseca questionnaire

healthy volunteers

Temporomandibular joint range of motion, Fonseca questionnaire, facial asymmetry, and massater and temporal pain threshold will be evaluated by measuring both TBI patients and healthy individuals. Temporomandibular movements will be measured with a disposable cardboard ruler.

Diagnostic Test: Fonseca questionnaire

Interventions

Fonseca questionnaireDIAGNOSTIC_TEST

Fonseca questionnaire for the evaluation of temporomandibular dysfunction

Also known as: Joint range of motion measurement,, pressure pain threshold measurement
Patients with traumatic brain injuryhealthy volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

30 Patient with traumatic brain injury 30 healthy volunteer

You may qualify if:

  • clinical diagnosis of traumatic brain injury not receiving treatment for temporomandibular joint dysfunction

You may not qualify if:

  • communication and cooperation problems, congenital or systemic disease affecting the head and neck region, being treated for TMED and having a history of orthognathic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya Beyhekim Research and Training Hospital

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersBrain Injuries, TraumaticHeadache

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 7, 2022

Study Start

November 5, 2022

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

October 26, 2022

Record last verified: 2022-10

Locations