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CompletedNCT04274985Updated Apr 8, 2025

Reliability, Validity of The Turkish Version of Fonseca Anamnestic Index

An observational study in Temporomandibular Joint Disorders, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by Gazi University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
249
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Temporomandibular Joint Disorders

Keywords

  • Validity
  • Reliability
  • Temporomandibular Joint Disorders
03

In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's enrollment of 249 is above the median of 100 across 216 observational studies indexed under Joint Diseases.

Browse Joint Diseases studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with temporomandibular disorders between the ages of 18-50

Inclusion criteria

  • Having a temporomandibular disorder
  • Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification

Exclusion criteria

Exclusion Criteria:

  • Pregnant,
  • Canser,
  • Trauma,
  • Neurologic disorder,
  • Infection,
  • Trigeminal or postherpatic neuralgia
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
249 participants (actual)
Patient registry
No

Groups and cohorts

  • 1

    Patients with temporomandibular disorders

    Other: Questionnaire application

Interventions

  • OtherQuestionnaire application

    Patients will complete the mentioned questionnaires.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 minutes

07

Study locations

1 site
  • Halime ARIKAN
    Ankara, Yenimahalle 06560, Turkey
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04274985
Lead sponsor
Gazi University
Responsible party
Halime ARIKAN (Research Assistant, Gazi University) — Principal investigator
First posted
Feb 18, 2020
Start date
Feb 1, 2022
Primary completion
Jul 1, 2022
Completion
Mar 31, 2023
Last update
Apr 8, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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