Turkish Version of Helkimo Clinical Dysfunction Index

NCT07371143 | Not Yet Recruiting

• 1 other identifier: 27.03.2025/61
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder (TMD)

Keywords

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

Outcome Measures

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.

  At baseline (Day 0).

Secondary Outcomes (5)

• Turkish Version of the Helkimo Clinical Dysfunction Index

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

• Numeric Pain Rating Scale (NPRS)

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

• Range of Jaw Movement

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

• Mandibular Function Impairment Questionnaire (MFIQ) Score

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

• Fonseca Anamnestic Index (FAI) Score

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

Study Arms (1)

Helkimo Index Study Group

Individuals who meet the inclusion criteria for the Turkish validity and reliability study of the Helkimo Clinical Dysfunction Index. All participants will undergo a comprehensive clinical examination and multiple scale assessments at baseline. To assess test-retest reliability, all participants will be re-evaluated after a two-week interval.

Other: Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying Scales

Interventions

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.

Helkimo Index Study Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sevgi Medical Center: lead

Study Sites (1)

Umay Private Oral and Dental Health Clinic

Istanbul, Turkey (Türkiye)

Location

Related Publications (8)

• Yildiz NT, Alkan A, Kulunkoglu BA. Validity and Reliability of the Turkish Version of Mandibular Function Impairment Questionnaire. Cranio. 2024 Mar;42(2):160-170. doi: 10.1080/08869634.2021.2004715. Epub 2021 Nov 18.

  PMID: 34789075 RESULT

• Stegenga B, de Bont LG, de Leeuw R, Boering G. Assessment of mandibular function impairment associated with temporomandibular joint osteoarthrosis and internal derangement. J Orofac Pain. 1993 Spring;7(2):183-95.

  PMID: 8358365 RESULT

• Kaynak BA, Tas S, Salkin Y. The accuracy and reliability of the Turkish version of the Fonseca anamnestic index in temporomandibular disorders. Cranio. 2023 Jan;41(1):78-83. doi: 10.1080/08869634.2020.1812808. Epub 2020 Aug 25.

  PMID: 32840464 RESULT

• Bevilaqua-Grossi D, Chaves TC, de Oliveira AS, Monteiro-Pedro V. Anamnestic index severity and signs and symptoms of TMD. Cranio. 2006 Apr;24(2):112-8. doi: 10.1179/crn.2006.018.

  PMID: 16711273 RESULT

• van der Weele LT, Dibbets JM. Helkimo's index: a scale or just a set of symptoms? J Oral Rehabil. 1987 May;14(3):229-37. doi: 10.1111/j.1365-2842.1987.tb00714.x.

  PMID: 3474383 RESULT

• Alonso-Royo R, Sanchez-Torrelo CM, Ibanez-Vera AJ, Zagalaz-Anula N, Castellote-Caballero Y, Obrero-Gaitan E, Rodriguez-Almagro D, Lomas-Vega R. Validity and Reliability of the Helkimo Clinical Dysfunction Index for the Diagnosis of Temporomandibular Disorders. Diagnostics (Basel). 2021 Mar 8;11(3):472. doi: 10.3390/diagnostics11030472.

  PMID: 33800185 RESULT

• Çınar, F., Şengül, H., Çapar, H., Çakmak, C., & Bilge, Y. (2018). Perception of health news: a scale development study. J Acad Res Nurs, 4(3), 164-171.

  RESULT

• Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.

  PMID: 15928561 RESULT

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

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

CONTACT

+905372100654; sultanigrek@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: January 25, 2026
• Primary Completion: February 15, 2026
• Study Completion: March 10, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)