Temporamandibular Joint Functions and Parafunctional Habits

October 2, 2023 updated by: Nurhayat KORKMAZ, Karadeniz Technical University

Investigation of Temporamandibular Joint Functions and Parafunctional Habits in Adolescents With Headache

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Trabzon, Turkey, 61000
        • Karadeniz Technical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adolescents 10-18 years old with headache and without headache

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Study group
Adolescent with headache, 10-18 ages
Control group
Adolescent without headache

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache Impact Test (HIT-6)
Time Frame: 1 day (one assessment)
1 day (one assessment)
Temporomandibular dysfunction
Time Frame: 1 day (one assessment)
Fonseca Anamnestic Index. No dysfunction, mild, moderate, severe
1 day (one assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wong Baker Pain Scale
Time Frame: 1 day (one assessment)
Severity of Headache
1 day (one assessment)
Mouth opening measurement
Time Frame: 1 day (one assessment)
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)
Pressure pain threshold
Time Frame: 1 day (one assessment)
Pressure pain thresholds of temporomandibular joint, masseter, temporalis, SCM and upper trapezius muscles
1 day (one assessment)
Parafunctional habits questionnaire
Time Frame: 1 day (one assessment)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Elif Acar Arslan, Assoc. Prof, Karadeniz Technical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

January 30, 2023

Study Completion (Actual)

March 13, 2023

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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