HeadacheNCT05580276
Temporamandibular Joint Functions and Parafunctional Habits
An observational study of Headache and Temporomandibular Disorder, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Headache, Temporomandibular Disorder
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2022to 13 Mar 2023
- 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 10 to 18 years
- All sexes
- Child, Adult
Study population: Adolescents 10-18 years old with headache and without headache
Who may be able to join
- 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
Who cannot join
- Being on any analgesic, anti-sedative, myorelaxant medication
- Those with mental and psychiatric problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Headache, Temporomandibular Disorder
- Keywords
- adolescent headache, temporomandibular dysfunction
- Medical subject headings
- Headache, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Adolescent with headache, 10-18 ages | |
| Control group | Adolescent without headache |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Impact Test (HIT-6)
Measured: 1 day (one assessment)
Temporomandibular dysfunction
Fonseca Anamnestic Index. No dysfunction, mild, moderate, severe
Measured: 1 day (one assessment)
Secondary outcomes (4)
Wong Baker Pain Scale
Severity of Headache
Measured: 1 day (one assessment)
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
Measured: 1 day (one assessment)
Pressure pain threshold
Pressure pain thresholds of temporomandibular joint, masseter, temporalis, SCM and upper trapezius muscles
Measured: 1 day (one assessment)
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
Measured: 1 day (one assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start10 Mar 2022
- Primary completion30 Jan 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhayat KORKMAZ, Karadeniz Technical University
- Investigators
- Elif Acar Arslan, Assoc. Prof, Study director, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580276
- Sponsor's protocol ID
- KTU-FTR-02
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2022
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Temporamandibular Joint Functions and Parafunctional Habits in Adolescents With Headache
- ClinicalTrials.gov ID
- NCT05580276
- Acronym / sponsor ID
- KTU-FTR-02
- Conditions
- Headache, Temporomandibular Disorder
- Keywords
- adolescent headache, temporomandibular dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 14 Oct 2022 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Adolescent with headache, 10-18 ages |
| Control group | – | –Adolescent without headache |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Adolescents 10-18 years old with headache and without headache
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Being on any analgesic, anti-sedative, myorelaxant medication
- Those with mental and psychiatric problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Headache Impact Test (HIT-6)
Time frame: 1 day (one assessment)
Temporomandibular dysfunction
Time frame: 1 day (one assessment)
Fonseca Anamnestic Index. No dysfunction, mild, moderate, severe
4 secondary outcomes
Wong Baker Pain Scale
Time frame: 1 day (one assessment)
Mouth opening measurement
Time frame: 1 day (one assessment)
Pressure pain threshold
Time frame: 1 day (one assessment)
Parafunctional habits questionnaire
Time frame: 1 day (one assessment)
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 4 Oct 2023.
- 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.
Elif Acar Arslan, Assoc. Prof study director
Karadeniz Technical University
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 Headache and Temporomandibular Disorder, run by Karadeniz Technical 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 3 inclusion and 2 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 4 Oct 2023. 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?
Headache Impact Test (HIT-6) (time frame: 1 day (one assessment)). The study lists 2 primary outcomes in all. 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 4 Oct 2023.