NCT03837587

Brief Summary

This study, we are aim to make the Turkish version validity and reliability of the Cranifacial Pain and Disability Inventory, Jaw Functional Limitation Scale-20, and Jaw Functional Limitation Scale-8.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

February 5, 2019

Last Update Submit

May 29, 2022

Conditions

Keywords

ValidityReliabilityTemporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (3)

  • Craniofacial Pain and Disability Inventory

    Craniofacial Pain and Disability Inventory is a questionnaire that development to individuals with temporomandibular disorders. Each item is scored between 0-3. The total score range from 0 to 63, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.

    10 minutes

  • Jaw Functional Limitation Scale-20

    Jaw Functional Limitation Scale-20 is a questionnaire that development to individuals with temporomandibular disorders. This questionnaire evaluates conditions of disability. Each item is scored between 0-10. It mean that "0= no limitation" and "10= severe limitation".The total score range from 0 to 200, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.

    10 minutes

  • Jaw Functional Limitation Scale-8

    Jaw Functional Limitation Scale-8 is a questionnaire that development to individuals with temporomandibular disorders. This questionnaire evaluates conditions of disability. It is short form of Jaw Functional Limitation Scale-20. Each item is scored between 0-10. It mean that "0= no limitation" and "10= severe limitation".The total score range from 0 to 80, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.

    5 minutes

Study Arms (1)

Patients group

Patients with temporomandibular disorders

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with temporomandibular disorders between the ages of 18-50

You may qualify if:

  • Having a temporomandibular disorder
  • Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification

You may not qualify if:

  • Pregnant,
  • Canser,
  • Trauma,
  • Neurologic disorder,
  • Infection,
  • Trigeminal or postherpatic neuralgia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (1)

  • Arikan H, Citaker S, Ucok C. Cross-cultural adaptation, reliability, and validity of the Turkish version of the Craniofacial Pain and Disability Inventory (CF-PDI/T) for individuals with temporomandibular disorders. Disabil Rehabil. 2023 Feb;45(3):523-533. doi: 10.1080/09638288.2022.2028909. Epub 2022 Feb 4.

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Seyit ÇITAKER, Prof. Dr.

    Gazi University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 12, 2019

Study Start

October 1, 2018

Primary Completion

April 1, 2021

Study Completion

February 1, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations