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NCT05029908 Clinical Trial

the Relationship Between Parafunctional Habits, Pain and Functional Limitation of the Jaw

Temporomandibular Disorder Clinical Trial

Official title:
Evaluation of the Relationship Between Parafunctional Habits, Pain and Functional Limitation of the Jaw in Temporomandibular Disorders

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05029908
Other study ID # 2021/209
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 25, 2021
Est. completion date September 8, 2021

Study information
Verified date September 2021
Source Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Description:

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. 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date September 8, 2021
Est. primary completion date September 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - aged 18-65 years - temporomandibular joint complaints for more than 3 months - cognitive ability to understand test instructions Exclusion Criteria: - history of previous temporomandibular joint operation, muscle, neurological or rheumatic disease that may affect temporomandibular joint - history of facial/cervical trauma or neoplasia

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Jaw Functional Limitation Scale
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.

Locations
Country Name City State
Turkey Cansin Medin Ceylan Istanbul None Selected

Sponsors (1)
Lead Sponsor Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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