Health TrialsbyHealthPanel

Turkish Version of Helkimo Clinical Dysfunction Index

ConditionTemporomandibular Disorder (TMD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorSevgi Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying Scales

    Other intervention

    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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Helkimo Index Study Group1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sevgi Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: