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.
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.
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.
- Conditions
- Temporomandibular Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Patients Who Have Temporomandibular Joint Disorder | Experimental | Helkimo index will be applied to the patients have temporomandibular disorder. Receives: Diagnostic Test: Helkimo Index |
| Healthy Controls | Experimental | Helkimo 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.
Helkimo Index for Diagnosis of Temporomandibular Disorders
Turkish Validity and Reliability Study
Measured: 3 months
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
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)
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.
- First posted1 Mar 2023
- Study start15 Mar 2023 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion26 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elif Tugce Cil, PhD, Study director, Yeditepe University
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT05749224
- Acronym / sponsor ID
- DenizOzluer
- Conditions
- Temporomandibular Disorder
- Keywords
- helkimo index, temporomandibular disorders, Turkish validity and reliability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 26 May 2023 (estimated)
- First posted
- 1 Mar 2023 (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.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Who Have Temporomandibular Joint Disorder | Experimental | Diagnostic Test: Helkimo IndexHelkimo index will be applied to the patients have temporomandibular disorder. |
| Healthy Controls | Experimental | Diagnostic Test: Helkimo IndexHelkimo index will be applied to healthy people. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age over 18
Key exclusion criteria (1 listed)
- History of TMJ surgery, having neuromuscular disorders, having vestibular symptoms which affects balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helkimo IndexHelkimo 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. | Diagnostic test | Healthy Controls, Patients Who Have Temporomandibular Joint Disorder |
Primary outcome
Helkimo Index for Diagnosis of Temporomandibular Disorders
Time frame: 3 months
Turkish Validity and Reliability Study
Questionnaire for Anamnestic Component of Helkimo Index
Time frame: 3 months
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.
Clinical Dysfunction Component of Helkimo Index
Time frame: 3 months
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.
1 secondary outcome
SF-12
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Validity and Reliability of the Helkimo Clinical Dysfunction Index for the Diagnosis of Temporomandibular DisordersLink provided by the sponsor.
- Analysis of Helkimo index for temporomandibular disorder diagnosis in the dental students of Faridabad city: A cross-sectional studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Cultural adaptation of the Helkimo index to Turkish society will be done.
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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 Tugce Cil, PhD study director
Yeditepe University
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.