Temporomandibular DisorderTMJNCT06623552
Relationship Between Cervical Pain and Temporomandibular Dysfunction Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility
An observational study of Temporomandibular Disorder, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to examine temporomandibular dysfunctions, jaw functional limitation, cervical mobility and craniovertebral angles and possible relations between individuals with cervical pain and individuals without cervical pain and to compare the this four variables between the two groups. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Neck Pain and Disability Scale (NPDS), Fonseca Anamnestic Index (FAI) and Evaluation of Jaw Functional Limitation
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 30 Mar 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All individuals in the study were included on a voluntary basis.All participants were informed about the study before the evaluations and the consent form was signed (Appendix- ).All necessary evaluations for the study were carried out on the same day.During the study, both the participants in the study group and the participants in the control group completed the evaluation completely.No health problems were observed in any participant during and after the evaluations.
Who may be able to join
- Neck pain disability score below 15 Not having painting problem for TME Being in the age range of 18-50 Volunteering to participate in the study
Who cannot join
- he presence of any orthopedic and / or neurological problem that may prevent evaluations.
- Being diagnosed with any psychiatric disorder Situations that will prevent evaluation or communication
- Illiterate individuals
- Head, neck and maxillofacial surgery operation history
- Conditions in systemic pathological conditions such as malignant condition, fracture and rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to examine temporomandibular dysfunctions, jaw functional limitation, cervical mobility and craniovertebral angles and possible relations between individuals with cervical pain and individuals without cervical pain and to compare the this four variables between the two groups.
Read the detailed description
This study was conducted with 129 individuals (mean age 34.08:years, M/F=52/77) to determine the possible relationships between Cervical Pain and Temporomandibular Dysfunction, Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility. Pati,ents were assessed with Neck Pain and Disability Questionnaire , Fonseka Anamnestic Index , goniometric measurements, ,Cervical Mobility Measurement. JFSL-20 questionnaire and Craniovertebral Angle measurement was made by photographic method.
- Conditions
- Temporomandibular Disorder
- Being tested
- Neck Pain and Disability Scale (NPDS), Fonseca Anamnestic Index (FAI), Evaluation of Jaw Functional Limitation
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck Pain and Disability Scale (NPDS)Other
The Turkish version of the Neck Pain and Disability Scale (NPDS), developed by Wheeler et al., was used for individuals with neck pain. The severity of neck pain is evaluated on a 5-point Likert scale; where 0 indicates "no pain" and 4 indicates "very severe pain". The score is higher in those with upper extremity symptoms.The cut-off value of this scale was set to 15 to detect disability-related neck pain.The cut-off value is mandatory to evaluate a patient or a particular group of patients for clinically significant neck pain by distinguishing it from insignificant pain
Fonseca Anamnestic Index (FAI)Other
It is a questionnaire consisting of 10 questions, including pain during the period, parafunctional habits, movement restriction, clicking, malocclusion, emotional stress.In this study, clinical signs relevant to each severity category of Fonseca's anamnestic index were used to detect the frequency of symptoms and to characterize the symptoms and clinical findings of TMD.The Turkish version of Fonseca's Anamnestic Index (FAI) questionnaire was used to assess the symptom severity.
Evaluation of Jaw Functional LimitationOther
The Jaw Functional Limitation Scale (JFLS) was developed as an 8-item scale for general functional limitation in the jaw. In the light of the obtained items and supporting psychometric data, it has been expanded and re-developed to include the verbal and non-verbal communication limitations that occur in a 20-item tool16 JFLS-20 is a tool with three structure contents (chewing, vertical mobility of jaw state and emotional and verbal statement) to evaluate functional state.Difficulty performing a determined task is graded from 0 (without limitation) to 10 (severe limitation). Higher scores are a more serious sign of functional limitation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | the population without cervical pain or with a cut off value of less than 15 for neck pain and disability score(NPDS) were selected as the control group Receives: Other: Neck Pain and Disability Scale (NPDS); Other: Fonseca Anamnestic Index (FAI); Other: Evaluation of Jaw Functional Limitation | |
| Study Group | the population without cervical pain or with a cut off value of more than 15 for neck pain and disability score(NPDS) were selected as the study group Receives: Other: Neck Pain and Disability Scale (NPDS); Other: Fonseca Anamnestic Index (FAI); Other: Evaluation of Jaw Functional Limitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Pain and Disability Scale (NPDS):
Measured: one day
Secondary outcomes (1)
Fonseca Anamnestic Index (FAI):
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Nov 2020
- Primary completion30 Mar 2021
- Study completion30 Mar 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
- Prospective
- Enrolment
- 129 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623552
- Sponsor's protocol ID
- TMJ
- Acronym
- TMJ
- Status last verified
- Sep 2024
- First submitted
- 30 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Cervical Pain and Temporomandibular Dysfunction Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility
- ClinicalTrials.gov ID
- NCT06623552
- Acronym / sponsor ID
- TMJ / TMJ
- Conditions
- Temporomandibular Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 2 Oct 2024 (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.
The aim of this study is to examine temporomandibular dysfunctions, jaw functional limitation, cervical mobility and craniovertebral angles and possible relations between individuals with cervical pain and individuals without cervical pain and to compare the this four variables between the two groups.
Detailed description
This study was conducted with 129 individuals (mean age 34.08:years, M/F=52/77) to determine the possible relationships between Cervical Pain and Temporomandibular Dysfunction, Craniovertebral Angle, Jaw Functional Limitation and Cervical Mobility. Pati,ents were assessed with Neck Pain and Disability Questionnaire , Fonseka Anamnestic Index , goniometric measurements, ,Cervical Mobility Measurement. JFSL-20 questionnaire and Craniovertebral Angle measurement was made by photographic method.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: Neck Pain and Disability Scale (NPDS), Other: Fonseca Anamnestic Index (FAI), Other: Evaluation of Jaw Functional Limitationthe population without cervical pain or with a cut off value of less than 15 for neck pain and disability score(NPDS) were selected as the control group |
| Study Group | – | Other: Neck Pain and Disability Scale (NPDS), Other: Fonseca Anamnestic Index (FAI), Other: Evaluation of Jaw Functional Limitationthe population without cervical pain or with a cut off value of more than 15 for neck pain and disability score(NPDS) were selected as the study group |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All individuals in the study were included on a voluntary basis.All participants were informed about the study before the evaluations and the consent form was signed (Appendix- ).All necessary evaluations for the study were carried out on the same day.During the study, both the participants in the study group and the participants in the control group completed the evaluation completely.No health problems were observed in any participant during and after the evaluations.
Key inclusion criteria (1 listed)
- Neck pain disability score below 15 Not having painting problem for TME Being in the age range of 18-50 Volunteering to participate in the study
Key exclusion criteria (5 listed)
- he presence of any orthopedic and / or neurological problem that may prevent evaluations.
- Being diagnosed with any psychiatric disorder Situations that will prevent evaluation or communication
- Illiterate individuals
- Head, neck and maxillofacial surgery operation history
- Conditions in systemic pathological conditions such as malignant condition, fracture and rheumatoid arthritis
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 |
|---|---|---|
| Neck Pain and Disability Scale (NPDS)The Turkish version of the Neck Pain and Disability Scale (NPDS), developed by Wheeler et al., was used for individuals with neck pain. The severity of neck pain is evaluated on a 5-point Likert scale; where 0 indicates "no pain" and 4 indicates "very severe pain". The score is higher in those with upper extremity symptoms.The cut-off value of this scale was set to 15 to detect disability-related neck pain.The cut-off value is mandatory to evaluate a patient or a particular group of patients for clinically significant neck pain by distinguishing it from insignificant pain | Other | Control Group, Study Group |
| Fonseca Anamnestic Index (FAI)It is a questionnaire consisting of 10 questions, including pain during the period, parafunctional habits, movement restriction, clicking, malocclusion, emotional stress.In this study, clinical signs relevant to each severity category of Fonseca's anamnestic index were used to detect the frequency of symptoms and to characterize the symptoms and clinical findings of TMD.The Turkish version of Fonseca's Anamnestic Index (FAI) questionnaire was used to assess the symptom severity. | Other | Control Group, Study Group |
| Evaluation of Jaw Functional LimitationThe Jaw Functional Limitation Scale (JFLS) was developed as an 8-item scale for general functional limitation in the jaw. In the light of the obtained items and supporting psychometric data, it has been expanded and re-developed to include the verbal and non-verbal communication limitations that occur in a 20-item tool16 JFLS-20 is a tool with three structure contents (chewing, vertical mobility of jaw state and emotional and verbal statement) to evaluate functional state.Difficulty performing a determined task is graded from 0 (without limitation) to 10 (severe limitation). Higher scores are a more serious sign of functional limitation. | Other | Control Group, Study Group |
Primary outcome
Neck Pain and Disability Scale (NPDS):
Time frame: one day
1 secondary outcome
Fonseca Anamnestic Index (FAI):
Time frame: one day
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 2 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Yeditepe University 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 1 inclusion and 5 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 2 Oct 2024. 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?
Neck Pain and Disability Scale (NPDS): (time frame: one day). 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 2 Oct 2024.