- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04274985
Reliability, Validity of The Turkish Version of Fonseca Anamnestic Index
April 6, 2025 updated by: Halime ARIKAN, Gazi University
The aim in this study is to determine the Turkish version validity and reliability of the Fonseca Anamnestic Index.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
249
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Yenimahalle
-
Ankara, Yenimahalle, Turkey, 06560
- Halime ARIKAN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients with temporomandibular disorders between the ages of 18-50
Description
Inclusion Criteria:
- Having a temporomandibular disorder
- Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification
Exclusion Criteria:
- Pregnant,
- Canser,
- Trauma,
- Neurologic disorder,
- Infection,
- Trigeminal or postherpatic neuralgia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Patients with temporomandibular disorders
|
Patients will complete the mentioned questionnaires.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2022
Primary Completion (Actual)
July 1, 2022
Study Completion (Actual)
March 31, 2023
Study Registration Dates
First Submitted
February 16, 2020
First Submitted That Met QC Criteria
February 16, 2020
First Posted (Actual)
February 18, 2020
Study Record Updates
Last Update Posted (Actual)
April 8, 2025
Last Update Submitted That Met QC Criteria
April 6, 2025
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91610558-604.01.02-
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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