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NCT Number: NCT07371143

Turkish Version of 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.

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Key information

Conditions

Temporomandibular Disorder (TMD) Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Umay Private Oral and Dental Health Clinic

Istanbul, Turkey (Türkiye)

Location contact

Sultan Igrek, Asst. Prof

CONTACT

[email protected]

+905372100654

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying Scales

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sultan Igrek (Istanbul Beykent University), Asst. Prof.

CONTACT

[email protected]

+905372100654

Sponsors and collaborators

Lead sponsor

Sevgi Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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