NCT07449221

Brief Summary

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 Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2026

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 27, 2026

Last Update Submit

February 27, 2026

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (5)

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

    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.

    30 minutes

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

    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.

    30 minutes

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

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

    30 minutes

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

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

    30 minutes

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

    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.

    2 days

Secondary Outcomes (2)

  • Visual Analogue Scale (VAS)

    30 minutes

  • Fonseca Anamnestic Index (FAI)

    30 minutes

Interventions

Questionnaire AdministrationOTHER

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult male and female patients diagnosed with temporomandibular disorders (TMD), aged 18 to 65 years, who are native Arabic speakers. Participants are recruited from El-Kasr Elainy jaw and dental clinics to evaluate the validity, reliability, feasibility, and cultural adaptation of the Arabic version of the 8-item Jaw Functional Limitation Scale (JFLS-8).

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El-Kasr Elainy jaw and dental clinics

Giza, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Salwa Fadl Abdel Mageed, PhD

    Professor, Cairo University

    STUDY CHAIR

  • Dina Sayed Abd Allah, PhD

    Lecturer, Cairo University

    STUDY DIRECTOR

  • Eman Sayed Ahmed Shalaby, PhD

    Lecturer, Cairo University

    STUDY DIRECTOR

Central Study Contacts

Wafaa Hashem Ahmed Hasan, B.Sc

CONTACT

+20 10 50861450wafaahashem859@gmail.com

Dina Sayed Abd Allah, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 4, 2026

Study Start

March 7, 2026

Primary Completion

May 7, 2026

Study Completion

May 15, 2026

Last Updated

March 4, 2026

Record last verified: 2026-02

Locations

EG(1)