- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05029908
the Relationship Between Parafunctional Habits, Pain and Functional Limitation of the Jaw
Evaluation of the Relationship Between Parafunctional Habits, Pain and Functional Limitation of the Jaw in Temporomandibular Disorders
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
None Selected
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Istanbul, None Selected, Turkey, 34147
- Cansın Medin Ceylan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Jaw Functional Limitation Scale
Time Frame: baseline
|
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).
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baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: cansın m ceylan, İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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