Turkish Version of Helkimo Clinical Dysfunction Index

N/ANot Yet RecruitingNCT07371143

Sevgi Medical Center48 enrolled

Overview

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.

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

Conditions

Temporomandibular Disorder (TMD)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Internal Consistency of the Turkish Helkimo Clinical Dysfunction Index

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.

Time frame: At baseline (Day 0).

Secondary Outcomes

Turkish Version of the Helkimo Clinical Dysfunction Index

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.

Time frame: Baseline (Day 0) and 14 days after the baseline assessment for test-retest reliability.

Numeric Pain Rating Scale (NPRS)

A subjective scale where participants rate their pain during palpation and chewing from 0 (no pain) to 10 (worst possible pain).

Time frame: Baseline (Day 0) and 14 days after the baseline assessment.

Range of Jaw Movement

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.

Time frame: Baseline (Day 0) and 14 days after the baseline assessment.

Mandibular Function Impairment Questionnaire (MFIQ) Score

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.

Time frame: Baseline (Day 0) and 14 days after the baseline assessment.

Fonseca Anamnestic Index (FAI) Score

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.

Time frame: Baseline (Day 0) and 14 days after the baseline assessment.

Turkish Version of Helkimo Clinical Dysfunction Index

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts