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Turkish Version of Helkimo Clinical Dysfunction Index

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07371143
Enrollment
48
Registered
2026-01-27
Start date
2026-01-25
Completion date
2026-03-10
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorder (TMD)

Keywords

temporomandibular disorder, helkimo clinical dysfunction Index, Turkish Adaptation, Reliability, and Validity

Brief summary

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.

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.

Interventions

OTHERTurkish 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.

Sponsors

Sevgi Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Internal Consistency of the Turkish Helkimo Clinical Dysfunction IndexAt 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.

Secondary

MeasureTime frameDescription
Turkish Version of the Helkimo Clinical Dysfunction IndexBaseline (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.
Numeric Pain Rating Scale (NPRS)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).
Range of Jaw MovementBaseline (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.
Mandibular Function Impairment Questionnaire (MFIQ) ScoreBaseline (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.
Fonseca Anamnestic Index (FAI) ScoreBaseline (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.

Countries

Turkey (Türkiye)

Contacts

CONTACTSultan Igrek (Istanbul Beykent University), Asst. Prof.
sultanigrek@gmail.com+905372100654

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026