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

Primary Purpose

Temporomandibular Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Helkimo Index
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Temporomandibular Disorder focused on measuring helkimo index, temporomandibular disorders, Turkish validity and reliability

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age over 18 Exclusion Criteria: History of TMJ surgery, having neuromuscular disorders, having vestibular symptoms which affects balance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Patients Who Have Temporomandibular Joint Disorder

    Healthy Controls

    Arm Description

    Helkimo index will be applied to the patients have temporomandibular disorder.

    Helkimo index will be applied to healthy people.

    Outcomes

    Primary Outcome Measures

    Helkimo Index for Diagnosis of Temporomandibular Disorders
    Turkish Validity and Reliability Study
    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.
    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.

    Secondary Outcome Measures

    SF-12
    Quality of life

    Full Information

    First Posted
    December 24, 2022
    Last Updated
    February 28, 2023
    Sponsor
    Yeditepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05749224
    Brief Title
    Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders
    Official Title
    Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 15, 2023 (Anticipated)
    Primary Completion Date
    May 15, 2023 (Anticipated)
    Study Completion Date
    May 26, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Yeditepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Disorder
    Keywords
    helkimo index, temporomandibular disorders, Turkish validity and reliability

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients Who Have Temporomandibular Joint Disorder
    Arm Type
    Experimental
    Arm Description
    Helkimo index will be applied to the patients have temporomandibular disorder.
    Arm Title
    Healthy Controls
    Arm Type
    Experimental
    Arm Description
    Helkimo index will be applied to healthy people.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Helkimo Index
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Helkimo Index for Diagnosis of Temporomandibular Disorders
    Description
    Turkish Validity and Reliability Study
    Time Frame
    3 months
    Title
    Questionnaire for Anamnestic Component of Helkimo Index
    Description
    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.
    Time Frame
    3 months
    Title
    Clinical Dysfunction Component of Helkimo Index
    Description
    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.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    SF-12
    Description
    Quality of life
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age over 18 Exclusion Criteria: History of TMJ surgery, having neuromuscular disorders, having vestibular symptoms which affects balance
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Deniz Ozluer, Master
    Phone
    +905327870367
    Email
    denizzozluer@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hazal Yeşilkaya, PhD
    Phone
    +905312281723
    Email
    yesilkayahazal@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elif Tugce Cil, PhD
    Organizational Affiliation
    Yeditepe University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Cultural adaptation of the Helkimo index to Turkish society will be done.
    IPD Sharing Time Frame
    In 2023 - Infinite Access
    IPD Sharing Access Criteria
    No access criteria
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8000811/pdf/diagnostics-11-00472.pdf
    Description
    Validity and Reliability of the Helkimo Clinical Dysfunction Index for the Diagnosis of Temporomandibular Disorders
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5308067/pdf/JIPS-17-48.pdf
    Description
    Analysis of Helkimo index for temporomandibular disorder diagnosis in the dental students of Faridabad city: A cross-sectional study

    Learn more about this trial

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

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