Temporomandibular Disorder (TMD)NCT07371143
Turkish Version of Helkimo Clinical Dysfunction Index
An observational study of Temporomandibular Disorder (TMD), run by Sevgi Medical Center at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Temporomandibular Disorder (TMD)
- What is being tested?
- Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying Scales
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2026to 10 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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),
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Umay Private Oral and Dental Health Clinic
Istanbul
Sultan Igrek, Asst. Prof, +905372100654, sultanigrek@gmail.com
About this study
Official title: Turkish Adaptation, Validity, and Reliability of the 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.
Read the detailed description
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.
- Conditions
- Temporomandibular Disorder (TMD)
- Being tested
- Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying Scales
- Keywords
- temporomandibular disorder, helkimo clinical dysfunction Index, Turkish Adaptation, Reliability, and Validity
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying ScalesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying Scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (Day 0).
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0) and 14 days after the baseline assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start25 Jan 2026 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorder (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sevgi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371143
- Sponsor's protocol ID
- 27.03.2025/61
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34789075Stegenga 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.
PubMed 8358365Kaynak 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.
PubMed 32840464Bevilaqua-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.
PubMed 16711273van 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.
PubMed 3474383Alonso-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.
PubMed 33800185Çınar, 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.
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.
PubMed 15928561
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation, Validity, and Reliability of the Helkimo Clinical Dysfunction Index
- ClinicalTrials.gov ID
- NCT07371143
- Acronym / sponsor ID
- 27.03.2025/61
- Conditions
- Temporomandibular Disorder (TMD)
- Keywords
- temporomandibular disorder, helkimo clinical dysfunction Index, Turkish Adaptation, Reliability, and Validity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sevgi Medical CenterUniversity, hospital or other
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Helkimo Index Study Group | – | Other: Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying ScalesIndividuals 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish Version of Helkimo Clinical Dysfunction Index and Accompanying ScalesThe 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. | Other | Helkimo Index Study Group |
Primary outcome
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.
5 secondary outcomes
Turkish Version of the Helkimo Clinical Dysfunction Index
Time frame: Baseline (Day 0) and 14 days after the baseline assessment for test-retest reliability.
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline (Day 0) and 14 days after the baseline assessment.
Range of Jaw Movement
Time frame: Baseline (Day 0) and 14 days after the baseline assessment.
Mandibular Function Impairment Questionnaire (MFIQ) Score
Time frame: Baseline (Day 0) and 14 days after the baseline assessment.
Fonseca Anamnestic Index (FAI) Score
Time frame: Baseline (Day 0) and 14 days after the baseline assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Results publication: PubMed 34789075Yildiz 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.
- Results publication: PubMed 8358365Stegenga 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.
- Results publication: PubMed 32840464Kaynak 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.
- Results publication: PubMed 16711273Bevilaqua-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.
- Results publication: PubMed 3474383van 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.
- Results publication: PubMed 33800185Alonso-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.
- Results publicationÇınar, 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.
- Results publication: PubMed 15928561Childs 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder (TMD), run by Sevgi Medical Center at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sultan Igrek (Istanbul Beykent University), Asst. Prof. (+905372100654, sultanigrek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency of the Turkish Helkimo Clinical Dysfunction Index (time frame: At baseline (Day 0).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07371143, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.