NCT05029908

Brief Summary

Temporomandibular disorders affect the general health and quality of life of individuals by causing deterioration in orofacial function and cause functional limitation. The use of Diagnostic Criteria for Temporomandibular Disorders (DC-TMD) is recommended for evidence-based evaluation of jaw joint disorders for clinical and research purposes.The aim of this study is to show the factors affecting the functional limitation of the jaw and to evaluate the relationship between the pain, Oral Behavioral Checklist and the Jaw Functional Limitation Scale (JFLS-8), using the Diagnostic Criteria for Temporomandibular Disorders (DC-TMD). 75 patients with temporomandibular disorder (TMD) who will apply to the outpatient clinic of Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included in our study. DC/TMD Axis I TMD Pain Screener Questionnaire, TMD Symptom Questionnaire, DC/TMD Axis II assessment tools 'Jaw Functional Limitation Scale-8 (JFLS-8) and Oral Behavioral Checklist (OBC) will be applied. In addition, demographic data will be questioned.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

August 30, 2021

Last Update Submit

September 21, 2021

Conditions

Keywords

temporomandibular disorderoral behavioral checklistDC/TMD

Outcome Measures

Primary Outcomes (1)

  • Jaw Functional Limitation Scale

    Jaw Functional Limitation Scale-8 (JFLS-8)is a scale in the DC / TMD Axis II section and aims to evaluate the functional limitation of the jaw. It consists of eight items that assess restraint due to temporomandibular problems, and these include changes in jaw motility (item 4), chewing (items 1-3), and verbal and emotional expression. (item 5-8).

    baseline

Study Arms (1)

TMD disorders

75 patients with temporomandibular disorder (TMD) who will apply to the outpatient clinic of Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included in our study. Ethics Committee approval was obtained from Bakırköy Sadi Konuk Training and Research Hospital before starting the study and a voluntary consent form will be signed by the patients before the evaluation. In this cross-sectional study; 75 participants aged 18-65 years who has temporomandibular joint (TMJ) complaints for more than 3 months and has the cognitive ability to understand test instructions will be included. Patients with a history of previous TMJ operation, muscle, neurological or rheumatic disease that may affect TMJ, and a history of facial/cervical trauma or neoplasia will excluded from the study.

Diagnostic Test: Jaw Functional Limitation Scale

Interventions

DC/TMD Axis I TMD Pain Screener Questionnaire and TMD Symptom Questionnaire will be administered to the participants. To determine parafunctional habits and limitation of function, the DC/TMD Axis II assessment tools 'Jaw Functional Limitation Scale-8 (JFLS-8) and Oral Behavioral Checklist (OBC) will be applied. In addition, demographic data (age, gender, education level, occupation) will be questioned.

TMD disorders

Eligibility Criteria

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

75 patients with temporomandibular disorder (TMD) who applied to the outpatient clinic of Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included in our study.

You may qualify if:

  • aged 18-65 years
  • temporomandibular joint complaints for more than 3 months
  • cognitive ability to understand test instructions

You may not qualify if:

  • history of previous temporomandibular joint operation, muscle, neurological or rheumatic disease that may affect temporomandibular joint
  • history of facial/cervical trauma or neoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cansın Medin Ceylan

Istanbul, None Selected, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersArthralgia

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • cansın m ceylan

    istanbul physical medicine and rehabilitation research and training hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 1, 2021

Study Start

April 25, 2021

Primary Completion

September 8, 2021

Study Completion

September 8, 2021

Last Updated

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations