El-Kasr Elainy jaw and dental clinics
Giza, Egypt
NCT Number: NCT07449221
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?
Trial opening soon.
Get Notified18 year–65 year
All sexes
Observational
Giza, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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).
Time frame: 30 minutes
It will be measured using Cronbach's alpha to confirm that all 8 items are measuring the same underlying construct.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Dina Sayed Abd Allah, PhD
CONTACT
Wafaa Hashem Ahmed Hasan, B.Sc
CONTACT
Cairo University
Other
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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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