NCT04274985

Brief Summary

The aim in this study is to determine the Turkish version validity and reliability of the Fonseca Anamnestic Index.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 8, 2025

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

February 16, 2020

Last Update Submit

April 6, 2025

Conditions

Keywords

ValidityReliabilityTemporomandibular Joint Disorders

Outcome Measures

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.

    5 minutes

Study Arms (1)

1

Patients with temporomandibular disorders

Other: Questionnaire application

Interventions

Patients will complete the mentioned questionnaires.

1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with temporomandibular disorders between the ages of 18-50

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halime ARIKAN

Ankara, Yenimahalle, 06560, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 16, 2020

First Posted

February 18, 2020

Study Start

February 1, 2022

Primary Completion

July 1, 2022

Study Completion

March 31, 2023

Last Updated

April 8, 2025

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations