Temporomandibular DisorderNCT03490643
An Investigation Of The Relationship Between Temporomandibular Disorder With Posture And Pedobarographic Analysis
A study testing Postural Analysis and plantar pressure analysis in people with Temporomandibular Disorder, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is, to evaluate the whole body posture and plantar pressure distributions in individuals with Temporomandibular Disorder and also in people with healthy temporomandibular joints. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Postural Analysis and plantar pressure analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2018to 15 May 2018
- Phase
- Interventional
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- clinical diagnosis of Temporomandibular Diseases
- clinical diagnosis of healthy temporomandibular joint
Who cannot join
- Trauma history
- Anatomic deformities and skeletal system fractures
- Orthopedic or rheumatic diseases diagnosed
- Pregnancy
- Having TMR treatment
- Being included in the physiotherapy program in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: Temporomandibular Rahatsızlığın Postür ve Pedobarografik Ölçüm Sonuçları Ile İlişkisinin Araştırılması
The aim of the study is, to evaluate the whole body posture and plantar pressure distributions in individuals with Temporomandibular Disorder and also in people with healthy temporomandibular joints. A study group aged between 18-35 years, 30 patients, who were diagnosed with Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) who applied us with jaw pain and 30 healthy people at the same age range as a control group were included in the study. Both groups received global postural assessments by using PostureScreen Mobile® (PSM) program which is using four side photographs and the New York Posture Scale (NYPS). Static pedobarographic measurements were taken.
- Conditions
- Temporomandibular Disorder
- Being tested
- Postural Analysis, plantar pressure analysis
- Keywords
- Plantar Pressure Distribution, Posture, Posturescreen Mobile, RDC/TMD, TMD
- 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.
Postural AnalysisOther
posture and plantar pressure analysis
plantar pressure analysisOther
posture and plantar pressure analysis
| Study group | Role | What they receive |
|---|---|---|
| TMD Group | Other | people who has TMD Receives: Other: Postural Analysis; Other: plantar pressure analysis |
| Control Group | Other | individuals who dont have healthy temporomandibular joint Receives: Other: Postural Analysis; Other: plantar pressure analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
flexion and extension degree
degree
Measured: 5 minutes
translation
cm
Measured: 5 minutes
Secondary outcomes (1)
plantar pressure distribution
kPa
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start28 Apr 2018
- Primary completion10 May 2018
- Study completion15 May 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem ergezen, Istanbul Medipol University Hospital
- Investigators
- Gizem Ergezen, Principal investigator, Medipol UniversityZeliha Candan Algun, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490643
- Sponsor's protocol ID
- 10840098-604.01.01-E.8466
- Status last verified
- May 2018
- First submitted
- 25 Mar 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporomandibular Rahatsızlığın Postür ve Pedobarografik Ölçüm Sonuçları Ile İlişkisinin Araştırılması
- ClinicalTrials.gov ID
- NCT03490643
- Acronym / sponsor ID
- 10840098-604.01.01-E.8466
- Conditions
- Temporomandibular Disorder
- Keywords
- Plantar Pressure Distribution, Posture, Posturescreen Mobile, RDC/TMD, TMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2018 (actual)
- Primary completion
- 10 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 6 Apr 2018 (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 the study is, to evaluate the whole body posture and plantar pressure distributions in individuals with Temporomandibular Disorder and also in people with healthy temporomandibular joints. A study group aged between 18-35 years, 30 patients, who were diagnosed with Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) who applied us with jaw pain and 30 healthy people at the same age range as a control group were included in the study. Both groups received global postural assessments by using PostureScreen Mobile® (PSM) program which is using four side photographs and the New York Posture Scale (NYPS). Static pedobarographic measurements were taken.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMD Group | Other | Other: Postural Analysis, Other: plantar pressure analysispeople who has TMD |
| Control Group | Other | Other: Postural Analysis, Other: plantar pressure analysisindividuals who dont have healthy temporomandibular joint |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- clinical diagnosis of Temporomandibular Diseases
- clinical diagnosis of healthy temporomandibular joint
Key exclusion criteria (6 listed)
- Trauma history
- Anatomic deformities and skeletal system fractures
- Orthopedic or rheumatic diseases diagnosed
- Pregnancy
- Having TMR treatment
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 |
|---|---|---|
| Postural Analysisposture and plantar pressure analysis | Other | Control Group, TMD Group |
| plantar pressure analysisposture and plantar pressure analysis | Other | Control Group, TMD Group |
Primary outcome
flexion and extension degree
Time frame: 5 minutes
degree
translation
Time frame: 5 minutes
cm
1 secondary outcome
plantar pressure distribution
Time frame: 2 minutes
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 23 Jul 2018.
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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.
Gizem Ergezen principal investigator
Medipol University
Zeliha Candan Algun study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postural Analysis and plantar pressure analysis in people with Temporomandibular Disorder, run by Istanbul Medipol University 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 2 inclusion and 6 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 23 Jul 2018. 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?
flexion and extension degree (time frame: 5 minutes). The study lists 2 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 23 Jul 2018.