Clinical trial NCT05580276: Temporamandibular Joint Functions and Parafunctional Habits
Official title: Investigation of Temporamandibular Joint Functions and Parafunctional Habits in Adolescents With Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Temporomandibular Disorder
Keywords: adolescent headache
temporomandibular dysfunction
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 48
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents 10-18 years old with headache and without headache

Brief summary: Headache is the most common type of pain in children and adolescents with effects on health-related quality of life (HrQoL), school attendance, and social functioning. The International Headache Society recognizes that secondary headaches can be attributed to temporamandibular joint (TMJ) problems. The primary aim of the study is to evaluate temporamandibular joint functions and parafunctional habits in adolescents with headache. The second aim is to examine the relationship between temporamandibular joint functions and parafunctional habits and headache.

Detailed description: 24 individuals under the age of 18 diagnosed with headache and 24 healthy controls will be included in the study. Age, height, weight characteristics and parafunctional habits of individuals will be recorded. The severity of headache and its effect on daily life, temporamandibular joint pain severity will be evaluated. Temporamandibular joint dysfunction severity will be determined and mouth openings will be measured.

Participants who meet the inclusion criteria will be included in the study group. Healthy volunteers without headache complaints will also be included in the study as a control group.In this study, which is planned to include those who meet the inclusion criteria and agree to participate in the study, written informed consent form will be obtained from all individuals and from their parents for those under the age of 18. The study will be carried out in accordance with the ethical principles of the Declaration of Helsinki. The study will be done through a questionnaire form and with anthropetric measurements. No invasive procedure will be applied. A p value of ≤0.05 will be considered significant in all statistics.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with headache according to the ICDH-II (International Classification of Headache Disorders 2nd edition) criteria published by IHS (International Headache Society) in 2004
* Having a headache complaint in the last 3 months
* Having a HIT-6 score of 50 or higher

Exclusion Criteria:

* Being on any analgesic, anti-sedative, myorelaxant medication
* Those with mental and psychiatric problems

Primary outcomes:
measure: Headache Impact Test (HIT-6)
timeFrame: 1 day (one assessment)
measure: Temporomandibular dysfunction
timeFrame: 1 day (one assessment)
Secondary outcomes:
measure: Wong Baker Pain Scale
timeFrame: 1 day (one assessment)
measure: Mouth opening measurement
timeFrame: 1 day (one assessment)
measure: Pressure pain threshold
timeFrame: 1 day (one assessment)
measure: Parafunctional habits questionnaire
timeFrame: 1 day (one assessment)
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
affiliation: Karadeniz Technical University
name: Elif Acar Arslan, Assoc. Prof
role: STUDY_DIRECTOR
References: