Temporomandibular Joint DisordersNCT04274985
Reliability, Validity of The Turkish Version of Fonseca Anamnestic Index
An observational study of Temporomandibular Joint Disorders, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The aim in this study is to determine the Turkish version validity and reliability of the Fonseca Anamnestic Index. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Questionnaire application
- How many people
- 249 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with temporomandibular disorders between the ages of 18-50
Who may be able to join
- Having a temporomandibular disorder
- Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification
Who cannot join
- Pregnant,
- Canser,
- Trauma,
- Neurologic disorder,
- Infection,
- Trigeminal or postherpatic neuralgia
Trial locations and contacts
1 site in 1 country.
About this study
The aim in this study is to determine the Turkish version validity and reliability of the Fonseca Anamnestic Index.
Read the detailed description
Approximately 60% of individuals with temporomandibular disorders (TMD) reported increased pain intensity from midlevel to severe. This was seen at the end of the intervention or work related activities in the quarter of individuals. Therefore, the correct diagnosis of TMD is very important to reduce the economic cost. Fonseca Anamnestic Index (FAI) is an easy and understandable questionnaire. This questionnaire consists of 10 questions that provide a versatile evaluation of the temporomandibular joint (TMJ) in the head and neck, whether there is pain during chewing, the presence of parafunctional habits, range of motion, joint sounds, malocclusion, and emotional stresses. The participants give one of the answers to the questions "Yes = 10 points, Sometimes = 5 points, No = 0 points". As a result of the total of the points, the participants are evaluated as "TMD-None = 0-15 points, Mild-TMD = 20-40 points, Moderate TMD = 45-60 points, Severe-TMD = 100 points". The aim of this study was to evaluate the validity and reliability of the Turkish version of FAI. The study of validity and reliability is planned with 50 individuals with TMD. The sociodemographic characteristics of the individuals will be questioned by the investigators and then the patients will be evaluated with FAI, Craniofacial Pain and Disability Inventory (CF-PDI), Neck Disability Index (NDI), Tampa Scale for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Headache Impact Test-6 (HIT-6), Jaw Functional Limitation Scale (JFLS) (Turkish version) and Visual Analogue Scale (VAS). The test-retest will be re-administered by face-to-face interview technique after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Questionnaire application
- Keywords
- Validity, Reliability, Temporomandibular Joint Disorders
- 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.
Questionnaire applicationOther
Patients will complete the mentioned questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with temporomandibular disorders Receives: Other: Questionnaire application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fonseca Anamnestic Index (FAI)
Fonseca Anamnestic Index (FAI) is an easy and understandable questionnaire. This questionnaire consists of 10 questions that provide a versatile evaluation of the temporomandibular joint (TMJ) in the head and neck, whether there is pain during chewing, the presence of parafunctional habits, range of motion, joint sounds, malocclusion, and emotional stresses. The participants give one of the answers to the questions "Yes = 10 points, Sometimes = 5 points, No = 0 points". As a result of the total of the points, the participants are evaluated as "TMD-None = 0-15 points, Mild-TMD = 20-40 points, Moderate TMD = 45-60 points, Severe-TMD = 100 points".It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Feb 2022
- Primary completion1 Jul 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime ARIKAN, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274985
- Sponsor's protocol ID
- 91610558-604.01.02-
- Status last verified
- Jan 2022
- First submitted
- 16 Feb 2020
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Arikan H, Citaker S, Ucok C. Psychometric properties of the Fonseca Anamnestic Index (FAI) for temporomandibular disorders: Turkish version, responsiveness, reliability, and validity study. Disabil Rehabil. 2024 Apr;46(7):1408-1415. doi: 10.1080/09638288.2023.2199221. Epub 2023 Apr 17.
PubMed 37066863
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability, Validity of The Turkish Version of Fonseca Anamnestic Index
- ClinicalTrials.gov ID
- NCT04274985
- Acronym / sponsor ID
- 91610558-604.01.02-
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Validity, Reliability, Temporomandibular Joint Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 18 Feb 2020 (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.
The aim in this study is to determine the Turkish version validity and reliability of the Fonseca Anamnestic Index.
Detailed description
Approximately 60% of individuals with temporomandibular disorders (TMD) reported increased pain intensity from midlevel to severe. This was seen at the end of the intervention or work related activities in the quarter of individuals. Therefore, the correct diagnosis of TMD is very important to reduce the economic cost. Fonseca Anamnestic Index (FAI) is an easy and understandable questionnaire. This questionnaire consists of 10 questions that provide a versatile evaluation of the temporomandibular joint (TMJ) in the head and neck, whether there is pain during chewing, the presence of parafunctional habits, range of motion, joint sounds, malocclusion, and emotional stresses. The participants give one of the answers to the questions "Yes = 10 points, Sometimes = 5 points, No = 0 points". As a result of the total of the points, the participants are evaluated as "TMD-None = 0-15 points, Mild-TMD = 20-40 points, Moderate TMD = 45-60 points, Severe-TMD = 100 points". The aim of this study was to evaluate the validity and reliability of the Turkish version of FAI. The study of validity and reliability is planned with 50 individuals with TMD. The sociodemographic characteristics of the individuals will be questioned by the investigators and then the patients will be evaluated with FAI, Craniofacial Pain and Disability Inventory (CF-PDI), Neck Disability Index (NDI), Tampa Scale for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Headache Impact Test-6 (HIT-6), Jaw Functional Limitation Scale (JFLS) (Turkish version) and Visual Analogue Scale (VAS). The test-retest will be re-administered by face-to-face interview technique after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Questionnaire applicationPatients with temporomandibular disorders |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with temporomandibular disorders between the ages of 18-50
Key inclusion criteria (2 listed)
- Having a temporomandibular disorder
- Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification
Key exclusion criteria (6 listed)
- Pregnant,
- Canser,
- Trauma,
- Neurologic disorder,
- Infection,
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 |
|---|---|---|
| Questionnaire applicationPatients will complete the mentioned questionnaires. | Other | 1 |
Primary outcome
Fonseca Anamnestic Index (FAI)
Time frame: 5 minutes
Fonseca Anamnestic Index (FAI) is an easy and understandable questionnaire. This questionnaire consists of 10 questions that provide a versatile evaluation of the temporomandibular joint (TMJ) in the head and neck, whether there is pain during chewing, the presence of parafunctional habits, range of motion, joint sounds, malocclusion, and emotional stresses. The participants give one of the answers to the questions "Yes = 10 points, Sometimes = 5 points, No = 0 points". As a result of the total of the points, the participants are evaluated as "TMD-None = 0-15 points, Mild-TMD = 20-40 points, Moderate TMD = 45-60 points, Severe-TMD = 100 points".It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Derived from this study: PubMed 37066863Arikan H, Citaker S, Ucok C. Psychometric properties of the Fonseca Anamnestic Index (FAI) for temporomandibular disorders: Turkish version, responsiveness, reliability, and validity study. Disabil Rehabil. 2024 Apr;46(7):1408-1415. doi: 10.1080/09638288.2023.2199221. Epub 2023 Apr 17.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Joint Disorders, run by Gazi University 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 8 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fonseca Anamnestic Index (FAI) (time frame: 5 minutes). 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 NCT04274985, which also lists 1 linked publication.
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 8 Apr 2025.