Turkish Version of Helkimo Clinical Dysfunction Index

January 18, 2026 updated by: Sevgi Medical Center

Turkish Adaptation, Validity, and Reliability of the Helkimo Clinical Dysfunction Index

This study aimed to translate the Helkimo Clinical Dysfunction Index (HCDI) into Turkish and to test its validity and reliability as an outcome measurement method in individuals with temporomandibular dysfunction (TMD). The study included 40 patients. Participants' pain intensity and range of jaw movement were measured, followed by the administration of the HDCI, the Fonseca Anamnestic Index (FAI), and the Mandibular Function Impairment Questionnaire (MFIQ). For test-retest reliability, the same questionnaire was administered again to the same patients two weeks later, and the FAI was used to test the validity of the questionnaire.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Based on the idea of making the Helkimo Clinical Dysfunction Index (HCDI) available in Turkish, our study aimed to translate this scoring system into Turkish and to test its validity and reliability as an outcome measurement method in individuals with temporomandibular dysfunction (TMD). The study aimed to include 40 patients. Pain intensity during palpation and chewing was measured using a numerical pain rating scale (NPRS), and range of jaw movement was measured using a linear ruler. Participants were then administered the HCDI, the Fonseca Anamnestic Index (FAI), and the Mandibular Function Impairment Questionnaire (MFIQ). To assess test-retest reliability, the same questionnaire was administered again to the same patients after two weeks. The FAI was used to test the validity of the questionnaire.

Study Type

Observational

Enrollment (Estimated)

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 Contact

  • Name: Sultan Igrek (Istanbul Beykent University), Asst. Prof.
  • Phone Number: +905372100654
  • Email: sultanigrek@gmail.com

Study Locations

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of individuals who visit the Umay Private Oral and Dental Health Clinic between March 2025 and May 2025. Participants will include those diagnosed with Temporomandibular Disorders (TMD) based on physical and clinical examinations by a specialist. The study will recruit adults who meet the specific inclusion criteria for the Turkish validity and reliability analysis of the Helkimo Clinical Dysfunction Index. The estimated duration of the data collection phase is 3 months.

Description

Inclusion Criteria:

  • Being between 18 and 60 years of age and having been diagnosed with TMB,
  • The person must be a volunteer to participate in the study,
  • The native language must be Turkish.

Exclusion Criteria:

  • Having a history of malignant conditions, trauma, or surgery in the cranial and cervical region,
  • Inability to cooperate,
  • Regular use of analgesic and anti-inflammatory drugs,
  • Having dentofacial anomalies,
  • Having active inflammatory arthritis,
  • Having metabolic diseases (gout, osteoporosis, Cushing's disease, and hyper/hypoparathyroidism),
  • Having connective tissue, rheumatological (systemic lupus erythematosus and scleroderma), and hematological disorders (anemia and leukemia),
  • Having a diagnosed psychiatric illness,
  • Having received physical therapy related to TMB less than 6 months ago,
  • Not being a native language of Turkish

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Helkimo Index Study Group
Individuals who meet the inclusion criteria for the Turkish validity and reliability study of the Helkimo Clinical Dysfunction Index. All participants will undergo a comprehensive clinical examination and multiple scale assessments at baseline. To assess test-retest reliability, all participants will be re-evaluated after a two-week interval.
Other: Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying Scales
The intervention includes a detailed clinical assessment and a series of questionnaires. Participants will provide demographic data, trauma, and surgical history. Clinical evaluation includes the measurement of pain and jaw movements. Subjective symptoms will be assessed using the Numerical Pain Rating Scale (NPRS), linear ruler, Fonseca Anamnestic Index (FAI), and Mandibular Function Impairment Questionnaire (MFIQ). The Turkish version of the Helkimo Index will be administered to test its validity and reliability. To evaluate test-retest reliability, the entire procedure will be repeated for a subgroup after 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal Consistency of the Turkish Helkimo Clinical Dysfunction Index
Time Frame: At baseline (Day 0).
Internal consistency will be evaluated using Cronbach's alpha coefficient. A value of 0.70 or higher is considered indicative of good internal consistency for the scale and its subscales.
At baseline (Day 0).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Turkish Version of the Helkimo Clinical Dysfunction Index
Time Frame: Baseline (Day 0) and 14 days after the baseline assessment for test-retest reliability.
This index is a clinical tool used to assess the severity of temporomandibular disorders (TMD) through a physical examination. It evaluates five clinical items: impaired range of mandibular mobility, impaired temporomandibular joint function, muscle pain on palpation, temporomandibular joint pain on palpation, and pain during mandibular movement. Each item is scored as 0, 1, or 5 points, with total scores ranging from 0 to 25. Higher scores indicate more severe clinical dysfunction. This measure will be used to evaluate the Turkish version's internal consistency and test-retest reliability.
Baseline (Day 0) and 14 days after the baseline assessment for test-retest reliability.
Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline (Day 0) and 14 days after the baseline assessment.
A subjective scale where participants rate their pain during palpation and chewing from 0 (no pain) to 10 (worst possible pain).
Baseline (Day 0) and 14 days after the baseline assessment.
Range of Jaw Movement
Time Frame: Baseline (Day 0) and 14 days after the baseline assessment.
The range of jaw movement, including maximum mouth opening, protrusion, and lateral excursions, will be measured in millimeters (mm) using a linear ruler. These measurements are used to determine the mobility sub-score of the Helkimo Clinical Dysfunction Index.
Baseline (Day 0) and 14 days after the baseline assessment.
Mandibular Function Impairment Questionnaire (MFIQ) Score
Time Frame: Baseline (Day 0) and 14 days after the baseline assessment.
A questionnaire consisting of 17 items to evaluate functional limitations in mandibular movements (e.g., chewing, speaking, yawning). Each item is scored from 0 (no difficulty) to 4 (impossible to perform). Higher total scores indicate a greater level of functional impairment.
Baseline (Day 0) and 14 days after the baseline assessment.
Fonseca Anamnestic Index (FAI) Score
Time Frame: Baseline (Day 0) and 14 days after the baseline assessment.
A multidimensional tool consisting of 10 items used to assess jaw function limitations, pain frequency, and parafunctional behaviors related to TMD. Each item is answered as "yes" (10 points), "no" (0 points), or "sometimes" (5 points). Total scores range from 0 to 100, where higher scores indicate greater severity of TMD. Severity is classified as: 0-15 (no TMD), 20-40 (mild), 45-65 (moderate), and 70-100 (severe TMD). This index will be used to evaluate concurrent validity with the Helkimo Index.
Baseline (Day 0) and 14 days after the baseline assessment.

Collaborators and Investigators

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

Sponsor

Sevgi Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

January 25, 2026

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

March 10, 2026

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 18, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27.03.2025/61

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.

Clinical Trials on Temporomandibular Disorder (TMD)

Clinical Trials on Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying Scales

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe