Temporomandibular Joint DisordersNCT06034756
Temporomandibular Joint Problems and Core Stabilization
An observational study of Temporomandibular Joint Disorders and Core Stability, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the relationship between temporomandibular joint problems, head posture, tongue strength, and endurance with core stabilization. Read more about this study
- Who is it for?
- Ages 18 to 31 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Core Stability
- What is being tested?
- TMJ dysfunction, Maximum pain-free mouth opening (MMO) and Forward head posture
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 15 Feb 2023
- 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 31 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: University students
Who may be able to join
- University students aged 18 and 31 who agreed to participate in the study
- signed the Informed Consent Form were included.
Who cannot join
- having a non-reducible disc problem,
- having surgery related to spine, abdomen and/or TMJ problem,
- history of trauma, cancer,
- presence of neurological problems, congenital anomaly, musculoskeletal problems, systemic disease, facial paralysis,
- receiving any treatment related to the spine and TMJ in less than six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporomandibular Joint Problems, Head Posture, Tongue Strength and Endurance and Core Stabilization With University Students
This study aimed to investigate the relationship between temporomandibular joint problems, head posture, tongue strength, and endurance with core stabilization.
Read the detailed description
This cross-sectional study was conducted on university students aged 18-31 between September 2022 and February 2023. In the evaluation of the students were used that the Fonseca's Anamnestic Questionnaire for temporomandibular joint dysfunction, Research Diagnostic Criteria for Temporomandibular Disorders Examination Form for maximum pain-free mouth opening, presence of sound in temporomandibular joint movements, and palpation parameters of temporomandibular joint and surrounding muscles, Craniovertebral Angle for forward head posture, and Iowa Oral Performance Instrument for tongue strength and endurance. In addition, the Trunk Flexor Endurance Test and Biering Sorenson Test were used for static endurance of the core muscles, and Sit-ups Test and Modified Push-ups Test were used for dynamic endurance of the core muscles.
- Conditions
- Temporomandibular Joint Disorders, Core Stability
- Being tested
- TMJ dysfunction, Maximum pain-free mouth opening (MMO), Forward head posture, Tongue strength and endurance, Static endurance evaluation of the trunk muscles
- Keywords
- temporomandibular disorders, core stability, head posture, tongue strength
- 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.
TMJ dysfunctionOther
Fonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The diagnostic accuracy of the FAQ was found to be high in identifying pain-related and intra-articular TMDs, and the cut-off point was set as 25 points. A score of 25 and above was accepted as the presence of TMD.
Maximum pain-free mouth opening (MMO)Other
The maximum pain-free mouth opening was recorded using a 15 cm ruler
Forward head postureOther
Forward head posture was evaluated by CVA using a goniometer. CVA was measured in degrees as the angle between the horizontal plane, the seventh cervical vertebra and the ear hole
Tongue strength and enduranceOther
Tongue strength and endurance were evaluated with IOPI (Medical LLC, Redmond, WA), which has been clinically validated and reliable
Static endurance evaluation of the trunk musclesOther
The Trunk Flexors Endurance Test and the Biering Sorenson Test were used. These static tests are measurements targeting the local core muscles.
Dynamic endurance evaluation of the core musclesOther
The Sit-ups and the Modified Push-ups Tests were used. These dynamic tests are measurements targeting the global core muscles.
What is being measured
The primary outcome is the main question the study is designed to answer.
TMJ dysfunction
Fonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The FAQ has a multi-factor evaluation structure. The questionnaire consists of ten questions about pain in TMJ, head, and joints, with answer options of "No, Sometimes and Yes." A score of 25 and above was accepted as the presence of TMD.
Measured: September 2022- February 2023
Maximum pain-free mouth opening (MMO)
The maximum pain-free mouth opening was recorded using a 15 cm ruler
Measured: September 2022- February 2023
Forward head posture
Forward head posture was evaluated by CVA using a goniometer.
Measured: September 2022- February 2023
Tongue strength and endurance
Tongue strength and endurance were evaluated with IOPI (Medical LLC, Redmond, WA), which has been clinically validated and reliable
Measured: September 2022- February 2023
Static endurance evaluation of the trunk muscles
The Trunk Flexors Endurance Test and the Biering Sorenson Test were used. These static tests are measurements targeting the local core muscles. The time the individuals maintained their position was recorded in seconds (sec) using a stopwatch.
Measured: September 2022- February 2023
Dynamic endurance evaluation of the core muscles:
The Sit-ups and the Modified Push-ups Tests were used. These dynamic tests are measurements targeting the global core muscles. The number of times the individuals could perform the movement for 30 sec was recorded.
Measured: September 2022- February 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Sep 2022
- Primary completion1 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazel Çelik Güzel, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06034756
- Sponsor's protocol ID
- 2022-18
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 29 Sep 2023
- 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 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporomandibular Joint Problems, Head Posture, Tongue Strength and Endurance and Core Stabilization With University Students
- ClinicalTrials.gov ID
- NCT06034756
- Acronym / sponsor ID
- 2022-18
- Conditions
- Temporomandibular Joint Disorders, Core Stability
- Keywords
- temporomandibular disorders, core stability, head posture, tongue strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 13 Sep 2023 (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.
This study aimed to investigate the relationship between temporomandibular joint problems, head posture, tongue strength, and endurance with core stabilization.
Detailed description
This cross-sectional study was conducted on university students aged 18-31 between September 2022 and February 2023. In the evaluation of the students were used that the Fonseca's Anamnestic Questionnaire for temporomandibular joint dysfunction, Research Diagnostic Criteria for Temporomandibular Disorders Examination Form for maximum pain-free mouth opening, presence of sound in temporomandibular joint movements, and palpation parameters of temporomandibular joint and surrounding muscles, Craniovertebral Angle for forward head posture, and Iowa Oral Performance Instrument for tongue strength and endurance. In addition, the Trunk Flexor Endurance Test and Biering Sorenson Test were used for static endurance of the core muscles, and Sit-ups Test and Modified Push-ups Test were used for dynamic endurance of the core muscles.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 31 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University students
Key inclusion criteria (2 listed)
- University students aged 18 and 31 who agreed to participate in the study
- signed the Informed Consent Form were included.
Key exclusion criteria (5 listed)
- having a non-reducible disc problem,
- having surgery related to spine, abdomen and/or TMJ problem,
- history of trauma, cancer,
- presence of neurological problems, congenital anomaly, musculoskeletal problems, systemic disease, facial paralysis,
- receiving any treatment related to the spine and TMJ in less than six months.
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 |
|---|---|---|
| TMJ dysfunctionFonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The diagnostic accuracy of the FAQ was found to be high in identifying pain-related and intra-articular TMDs, and the cut-off point was set as 25 points. A score of 25 and above was accepted as the presence of TMD. | Other | – |
| Maximum pain-free mouth opening (MMO)The maximum pain-free mouth opening was recorded using a 15 cm ruler | Other | – |
| Forward head postureForward head posture was evaluated by CVA using a goniometer. CVA was measured in degrees as the angle between the horizontal plane, the seventh cervical vertebra and the ear hole | Other | – |
| Tongue strength and enduranceTongue strength and endurance were evaluated with IOPI (Medical LLC, Redmond, WA), which has been clinically validated and reliable | Other | – |
| Static endurance evaluation of the trunk musclesThe Trunk Flexors Endurance Test and the Biering Sorenson Test were used. These static tests are measurements targeting the local core muscles. | Other | – |
| Dynamic endurance evaluation of the core musclesThe Sit-ups and the Modified Push-ups Tests were used. These dynamic tests are measurements targeting the global core muscles. | Other | – |
Primary outcome
TMJ dysfunction
Time frame: September 2022- February 2023
Fonseca's Anamnestic Questionnaire (FAQ) was used for TMJ dysfunction. The FAQ has a multi-factor evaluation structure. The questionnaire consists of ten questions about pain in TMJ, head, and joints, with answer options of "No, Sometimes and Yes." A score of 25 and above was accepted as the presence of TMD.
Maximum pain-free mouth opening (MMO)
Time frame: September 2022- February 2023
The maximum pain-free mouth opening was recorded using a 15 cm ruler
Forward head posture
Time frame: September 2022- February 2023
Forward head posture was evaluated by CVA using a goniometer.
Tongue strength and endurance
Time frame: September 2022- February 2023
Tongue strength and endurance were evaluated with IOPI (Medical LLC, Redmond, WA), which has been clinically validated and reliable
Static endurance evaluation of the trunk muscles
Time frame: September 2022- February 2023
The Trunk Flexors Endurance Test and the Biering Sorenson Test were used. These static tests are measurements targeting the local core muscles. The time the individuals maintained their position was recorded in seconds (sec) using a stopwatch.
Dynamic endurance evaluation of the core muscles:
Time frame: September 2022- February 2023
The Sit-ups and the Modified Push-ups Tests were used. These dynamic tests are measurements targeting the global core muscles. The number of times the individuals could perform the movement for 30 sec was recorded.
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 29 Sep 2023.
- 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 Joint Disorders and Core Stability, run by Bandırma Onyedi Eylül 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 2 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 29 Sep 2023. 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?
TMJ dysfunction (time frame: September 2022- February 2023). The study lists 6 primary outcomes in all. 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 29 Sep 2023.