NCT05749224

Turkish Validity and Reliability of The Helkimo Index for Diagnosis of Temporomandibular Disorders

Status unknown NA Last updated 1 March 2023

What this trial tests

NA trial testing Helkimo Index in Temporomandibular Disorder in 100 participants. Status unknown.

Timeline

15 March 2023

Primary endpoint
15 May 2023

26 May 2023

Quick facts

Lead sponsor	Yeditepe University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	diagnostic
Enrollment	100
Start date	15 March 2023
Primary completion	15 May 2023
Estimated completion	26 May 2023

Drugs / interventions tested

• Helkimo Index

Conditions studied

• Temporomandibular Disorder — all drugs for Temporomandibular Disorder →

Sponsor

Yeditepe University

Who can join

Eligibility, any sex, with Temporomandibular Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Helkimo Index evaluates movement, joint function, pain and musculature, providing a quick general overview that could be very useful at different levels of care. The aim of this study is to investigate the validity and reliability of the Turkish version of the Helkimo index. Registration of subjective symptoms applying for the Helkimo Index required a questionnaire-based survey. Questionnaire comprised two parts: Anamnestic component which includes answers to questions in "yes" or "no". Clinical dysfunction part comprised clinical examination. Method: Turkish translation of Helkimo index will be made. The sample will consist of 100 subjects, 50 TMD patients and 50 healthy controls. the patients will be selected, demographic data were recorded: age, sex, height, weight, body mass index (BMI), educational level, work situation, smoking status, alcoholic habits and physical activity. Helkimo Index is comprised of five items, with each assessment having three possible answers, scored as 0, 1 or 5. The first item is related to the limitation in the range of jaw movement. The second item evaluates the alterations of joint function that produce deviations, sounds and/or joint locks or blockages; the third item evaluates the presence of pain when performing some movements; the fourth item evaluates muscular pain in the masticatory muscles; and the fifth item evaluates the presence of discomfort or pain in the prearticular area of the temporomandibular joint (TMJ) through palpation. From the sum of the 5 items, we identify no TMJ involvement if the score is 0, mild TMJ involvement when the score ranges from 1 to 9, moderate TMJ involvement if the score ranges between 10 and 19 and severe TMJ involvement for a score between 20 and 25. The Numerical Pain-Rating Scale (NPRS) test, disability, the Neck Disability Index test, the Dizziness Handicap Inventory (DHI), the Headache Impact Test (HIT-6) and 12-item Short-Form Health Survey (SF-12) will be assessed. Correlation will be made between the Helkimo index and these rating scales.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.