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Temporomandibular DisorderNCT05749224

Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders

A study testing Helkimo Index in people with Temporomandibular Disorder, run by Yeditepe University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Helkimo Index evaluates movement, joint function, pain and musculature, providing a quick general overview that could be very useful at different levels of care. The aim of this study is to investigate the validity and reliability of the Turkish version of the Helkimo index. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Temporomandibular Disorder
What is being tested?
Helkimo Index
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
15 Mar 2023to 26 May 2023
Phase
Interventional
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Age over 18

Who cannot join

  • History of TMJ surgery, having neuromuscular disorders, having vestibular symptoms which affects balance

Trial locations and contacts

No sites are listed yet.

Deniz Ozluer, Master contact

+905327870367

denizzozluer@gmail.com

Hazal Yeşilkaya, PhD contact

+905312281723

yesilkayahazal@gmail.com

About this study

Helkimo Index evaluates movement, joint function, pain and musculature, providing a quick general overview that could be very useful at different levels of care. The aim of this study is to investigate the validity and reliability of the Turkish version of the Helkimo index. Registration of subjective symptoms applying for the Helkimo Index required a questionnaire-based survey. Questionnaire comprised two parts: Anamnestic component which includes answers to questions in "yes" or "no". Clinical dysfunction part comprised clinical examination. Method: Turkish translation of Helkimo index will be made. The sample will consist of 100 subjects, 50 TMD patients and 50 healthy controls. the patients will be selected, demographic data were recorded: age, sex, height, weight, body mass index (BMI), educational level, work situation, smoking status, alcoholic habits and physical activity. Helkimo Index is comprised of five items, with each assessment having three possible answers, scored as 0, 1 or 5. The first item is related to the limitation in the range of jaw movement. The second item evaluates the alterations of joint function that produce deviations, sounds and/or joint locks or blockages; the third item evaluates the presence of pain when performing some movements; the fourth item evaluates muscular pain in the masticatory muscles; and the fifth item evaluates the presence of discomfort or pain in the prearticular area of the temporomandibular joint (TMJ) through palpation. From the sum of the 5 items, we identify no TMJ involvement if the score is 0, mild TMJ involvement when the score ranges from 1 to 9, moderate TMJ involvement if the score ranges between 10 and 19 and severe TMJ involvement for a score between 20 and 25. The Numerical Pain-Rating Scale (NPRS) test, disability, the Neck Disability Index test, the Dizziness Handicap Inventory (DHI), the Headache Impact Test (HIT-6) and 12-item Short-Form Health Survey (SF-12) will be assessed. Correlation will be made between the Helkimo index and these rating scales.

Read the detailed description

Temporomandibular disorder (TMD) is a wide-ranging term used to describe a number of related disorders involving the temporomandibular joint (TMJ), masticatory muscles, and occlusion, with common symptoms such as pain, restricted movement, muscle tenderness, and intermittent joint sounds. TMDs can also be defined as a collective term for conditions that involve pain and/or dysfunction of the TMJ and the related structures. The Helkimo Clinical Dysfunction Index (HCDI) has been widely used for the clinical diagnosis of TMDs. It is a simple and quick test that assesses limitations of mandibular movement, pain and joint function. However, the studies that analyze the reliability and validity of this tool are old, used a very small sample, applied incorrect statistical techniques and were limited to the analysis of a single clinometric property. The diagnostic validity of the HCDI was measured according to diagnostic criteria for temporomandibular disorders (DC/TMDs) protocol, which is the gold-standard diagnostic test for TMD. The DC/TMD protocol is composed of 12 items that assess muscle and joint pain, pain during jaw movement, headache, bites, noise, obstacles or blockages during jaw movement and discomfort in the palpation of the muscles of the temporomandibular joint. Finally, a diagnostic tree is used to specify a diagnostic result. The DC/TMD protocol has a sensitivity of 86%, a specificity of 98% and an inter-examination reliability of 85%. The main measure was the HCDI. The instrument is comprised of five items, with each assessment having three possible answers, scored as 0, 1 or 5. The first item is related to the limitation in the range of jaw movement. The second item evaluates the alterations of joint function that produce deviations, sounds and/or joint locks or blockages; the third item evaluates the presence of pain when performing some movements; the fourth item evaluates muscular pain in the masticatory muscles; and the fifth item evaluates the presence of discomfort or pain in the prearticular area of the temporomandibular joint (TMJ) through palpation. From the sum of the 5 items, we identify no TMJ involvement if the score is 0, mild TMJ involvement when the score ranges from 1 to 9, moderate TMJ involvement if the score ranges between 10 and 19 and severe TMJ involvement for a score between 20 and 25.

Pain perception will be evaluated by the Numerical Pain-Rating Scale (NPRS) test. The subjects indicate their perceived pain with a number between 0 (no pain) and 10 (the worst pain possible). This tool is used to quantify both the neck and the temporomandibular joint and is the pain assessment.

To evaluate the possibility of associate neck disability, the Neck Disability Index test will be used; it is a 10-question survey, with answers being reported as a number between 0 and 5. For each question, a score of 0 refers to the total absence of disability, while a score of 5 refers to total disability. In this line, a total score between 0 and 5 indicates absence of disability, 5-14 points indicate low disability, 15-24 point indicates moderate disability and 35-50 points indicate great disability.

The presence of vertigo and balance problems will be assessed by the Dizziness Handicap Inventory (DHI). This questionnaire is composed of 25 questions that can be answered with yes, no or sometimes, scoring 4, 0 and 2 points, respectively. This questionnaire assesses physical, emotional and functional dimensions, each of which has an independent score in addition to the total score.

Headache-associated symptoms will be measured with the Headache Impact Test (HIT-6), which is an evaluation questionnaire consisting of six questions that can be answered with usual, almost always, sometimes, rarely and never, with a total score between 36 and 78 points.

Finally, the quality of life will be assessed using the 12-item Short-Form Health Survey (SF-12). This questionnaire is the short version of the SF-36 and retains its self-administered form. It results in a Mental Component Summary score and a Physical Component Summary score (PCS-12), differentiating between the two components of the quality of life.

Being tested
Helkimo Index
Keywords
helkimo index, temporomandibular disorders, Turkish validity and reliability
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Helkimo IndexDiagnostic test

    Helkimo Index is comprised of five items, with each assessment having three possible answers, scored as 0, 1 or 5. The first item is related to the limitation in the range of jaw movement. The second item evaluates the alterations of joint function that produce deviations, sounds and/or joint locks or blockages; the third item evaluates the presence of pain when performing some movements; the fourth item evaluates muscular pain in the masticatory muscles; and the fifth item evaluates the presence of discomfort or pain in the prearticular area of the temporomandibular joint (TMJ) through palpation. From the sum of the 5 items, we identify no TMJ involvement if the score is 0, mild TMJ involvement when the score ranges from 1 to 9, moderate TMJ involvement if the score ranges between 10 and 19 and severe TMJ involvement for a score between 20 and 25.

Study groups in NCT05749224
Study groupRoleWhat they receive
Patients Who Have Temporomandibular Joint DisorderExperimentalHelkimo index will be applied to the patients have temporomandibular disorder.
Receives: Diagnostic Test: Helkimo Index
Healthy ControlsExperimentalHelkimo index will be applied to healthy people.
Receives: Diagnostic Test: Helkimo Index

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Helkimo Index for Diagnosis of Temporomandibular Disorders

    Turkish Validity and Reliability Study

    Measured: 3 months

  2. Questionnaire for Anamnestic Component of Helkimo Index

    It is an anamnestic component questionnaire consisting of 8 different questions asked verbally to the participants and forming the first part of the Helkimo index.

    Measured: 3 months

  3. Clinical Dysfunction Component of Helkimo Index

    It is a clinical dysfunction questionnaire that constitutes the second part of the helkimo index, in which the temporamandibular joint of the participants is evaluated physically with 5 different parameters.

    Measured: 3 months

Secondary outcomes (1)
  1. SF-12

    Quality of life

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2023
  2. Study start15 Mar 2023 (estimated)
  3. Primary completion15 May 2023 (estimated)
  4. Study completion26 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05749224
Sponsor's protocol ID
DenizOzluer
Status last verified
Dec 2022
First submitted
24 Dec 2022
Last updated
1 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Cultural adaptation of the Helkimo index to Turkish society will be done.

Questions about this trial

What is this clinical trial studying?

A study testing Helkimo Index in people with Temporomandibular Disorder, run by Yeditepe University.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Deniz Ozluer, Master (+905327870367, denizzozluer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Helkimo Index for Diagnosis of Temporomandibular Disorders (time frame: 3 months). The study lists 3 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 1 Mar 2023.

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