Temporomandibular DisorderNCT05029908
the Relationship Between Parafunctional Habits, Pain and Functional Limitation of the Jaw
An observational study of Temporomandibular Disorder and Pain, Joint, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Disorder, Pain, Joint
- What is being tested?
- Jaw Functional Limitation Scale
- Type of treatment
- Pill or oral medicine
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Apr 2021to 8 Sep 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- aged 18-65 years
- temporomandibular joint complaints for more than 3 months
- cognitive ability to understand test instructions
Who cannot join
- history of previous temporomandibular joint operation, muscle, neurological or rheumatic disease that may affect temporomandibular joint
- history of facial/cervical trauma or neoplasia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cansın Medin Ceylan
Istanbul, None Selected, 34147
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporomandibular Disorder, Pain, Joint
- Being tested
- Jaw Functional Limitation Scale
- Keywords
- temporomandibular disorder, oral behavioral checklist, DC/TMD
- Medical subject headings
- Temporomandibular Joint Disorders, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jaw Functional Limitation ScaleDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Jaw Functional Limitation Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start25 Apr 2021
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Cansin Medin, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- cansın m ceylan, Principal investigator, istanbul physical medicine and rehabilitation research and training hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029908
- Sponsor's protocol ID
- 2021/209
- Status last verified
- Sep 2021
- First submitted
- 30 Aug 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Parafunctional Habits, Pain and Functional Limitation of the Jaw in Temporomandibular Disorders
- ClinicalTrials.gov ID
- NCT05029908
- Acronym / sponsor ID
- 2021/209
- Conditions
- Temporomandibular Disorder, Pain, Joint
- Keywords
- temporomandibular disorder, oral behavioral checklist, DC/TMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMD disorders | – | Diagnostic Test: Jaw Functional Limitation Scale75 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- aged 18-65 years
- temporomandibular joint complaints for more than 3 months
- cognitive ability to understand test instructions
Key exclusion criteria (2 listed)
- history of previous temporomandibular joint operation, muscle, neurological or rheumatic disease that may affect temporomandibular joint
- history of facial/cervical trauma or neoplasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jaw Functional Limitation ScaleDC/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. | Diagnostic test | TMD disorders |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
cansın m ceylan principal investigator
istanbul physical medicine and rehabilitation research and training hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder and Pain, Joint, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jaw Functional Limitation Scale (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.