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NCT Number: NCT07449221

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

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?

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

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 outcomes

  1. Face Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

    Time frame: 30 minutes

    It will be assessed using the Clarity Index and Expert Proportion of Clearance, judged by two expert panels (5 experts each) to evaluate whether the scale appears clear and relevant.

  2. Content Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

    Time frame: 30 minutes

    It will be assessed using the Content Validity Index (CVI) and Expert Proportion of Relevance, to confirm that the 8 items adequately cover the construct of jaw functional limitation.

  3. Feasibility of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

    Time frame: 30 minutes

    It will be evaluated by two factors: time needed to complete the questionnaire and the missed item index (ratio of unanswered items).

  4. Internal Consistency Reliability of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

    Time frame: 30 minutes

    It will be measured using Cronbach's alpha to confirm that all 8 items are measuring the same underlying construct.

  5. Test-Retest Reliability of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

    Time frame: 2 days

    It will be assessed using Spearman's rank correlation coefficient, with a subset of patients completing the JFLS-8 again after 2 days under the same conditions.

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 30 minutes

    a 10 cm pain intensity scale measuring jaw pain during activity (recorded in cm), used to assess convergent validity with the JFLS-8.

  2. Fonseca Anamnestic Index (FAI)

    Time frame: 30 minutes

    a 10-item questionnaire classifying TMD severity (scores: 0-15 = no TMD; 20-40 = mild; 45-65 = moderate; 70-100 = severe), also used for convergent/construct validity testing.

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Sayed Abd Allah, PhD

CONTACT

Wafaa Hashem Ahmed Hasan, B.Sc

CONTACT

[email protected]

+20 10 50861450

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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