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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05580276
Other study ID # KTU-FTR-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 10, 2022
Est. completion date March 13, 2023

Study information

Verified date October 2023
Source Karadeniz Technical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date March 13, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Karadeniz Technical University Trabzon

Sponsors (1)

Lead Sponsor Collaborator
Karadeniz Technical University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Headache Impact Test (HIT-6) 1 day (one assessment)
Primary Temporomandibular dysfunction Fonseca Anamnestic Index. No dysfunction, mild, moderate, severe 1 day (one assessment)
Secondary Wong Baker Pain Scale Severity of Headache 1 day (one assessment)
Secondary Mouth opening measurement Maximum painless mouth opening width and lateral deviations from the distance between the two anterior incisors in the lower and upper palate 1 day (one assessment)
Secondary Pressure pain threshold Pressure pain thresholds of temporomandibular joint, masseter, temporalis, SCM and upper trapezius muscles 1 day (one assessment)
Secondary Parafunctional habits questionnaire Teeth clenching, teeth grinding, lip biting, excessive gum chewing, pencil biting, nail biting, hands on chin, chewing on one side only, sleeping on one side only 1 day (one assessment)
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