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Not yet recruiting NCT07449221

Cross Cultural Adaptation, Reliability &Validity of The Arabic Version of 8_Item Jaw Functional Limitation Scale In Temporomandibular Joint Disorders

Observational Temporomandibular Joint Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire Administration.
Who it may be relevant to
Registry conditions: Temporomandibular Joint Disorders. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The purpose of this study is to test if the translated Arabic version of the (jaw functional limitation scale -8) JFLS\_8 , valid (face, content, feasibility) ,reliable (internal consistency, test retest) and culturally adapted enough to quantify the impact of temporomandibular joint (TMJ) disorders on jow function in arabic people or not?

Detailed description

Temporomandibular disorders (TMD) are relatively prevalent among adults, representing a considerable health concern. These disorders negatively affect psychological well-being and overall quality of life, highlighting the importance of accurate assessment and appropriate management strategies. Consequently, there is a growing need for reliable and efficient tools to assess functional limitations associated with TMD.

The Jaw Functional Limitation Scale with 8 items (JFLS-8) is a concise, valid, and reliable instrument used for the assessment of functional limitations related to the masticatory system. It was developed as a shorter version of the JFLS-20 and has been shown to be more practical for use in busy clinical settings while maintaining strong psychometric properties. The JFLS-8 has demonstrated excellent validity and reliability and has been successfully translated and culturally adapted into several languages, confirming its effectiveness as a clinical assessment tool.

Therefore, there is a clear need to translate the JFLS-8 into an Arabic version, perform cultural adaptation, and evaluate its validity and reliability among patients with temporomandibular disorders in Arabic-speaking populations.

Interventions

  • Other Questionnaire Administration
    Participants complete the Arabic version of the 8-item Jaw Functional Limitation Scale (JFLS-8), along with reference measures (Visual Analogue Scale and Fonseca Anamnestic Index), to evaluate validity, reliability, feasibility, and cultural adaptation of the questionnaire. A subset of participants completes the JFLS-8 again after 2 days to assess test-retest reliability.

Primary outcome measures

  • Face Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8) [Time frame: 30 minutes]
  • Content Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8) [Time frame: 30 minutes]
  • Feasibility of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8) [Time frame: 30 minutes]
  • Internal Consistency Reliability of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8) [Time frame: 30 minutes]
  • Test-Retest Reliability of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8) [Time frame: 2 days]
Secondary outcome measures (2)
  • Visual Analogue Scale (VAS) [Time frame: 30 minutes]
  • Fonseca Anamnestic Index (FAI) [Time frame: 30 minutes]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 to 65 years .
  • Diagnosis of temporomandibular disorders ) jaw pain-popping sounds in the jaw -limited jaw movements - orofacial pain ) for one month at least, not receiving actual treatment for the orofacial region (splinting)
  • Being conscious and oriented.
  • Able to read and write in Arabic.
  • Both Genders were included.

Exclusion criteria

  • History of trauma (recent head or neck or TMJ severe trauma)
  • Recent surgery at the neck, head or TMJ
  • Diagnosed systemic and psychiatric diseases; diseases that may affect the TMJ, such as ankylosing spondylitis or rheumatoid arthritis; and pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Egypt · 1 center
  • El-Kasr Elainy jaw and dental clinics — Giza

Identifiers

NCT: NCT07449221 · P.T.REC/012/006224

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗