Scoliosis PatientsNCT04592133
Prospective Evaluation of Temporomandibular Joint Pathologies in Scoliosis Patients With Ultrasonography and Clinical Examination
An observational study of Scoliosis Patients, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
From the anatomical and functional point of view, stomatognathic system and spine have close connections. Together with the complex neuromuscular relationships, this creates an important area of cooperation between dentists and orthopedics (1). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Scoliosis Patients
- What is being tested?
- Ultrasonography
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 3 Jan 2021
- How long will I take part?
- 6 Months
- 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 12 to 18 years
- All sexes
- Child, Adult
Study population: All patient population admitted to our clinic
Who may be able to join
- Being between the ages of 12-18
- Being diagnosed with Adolescent Idiopathic Scoliosis
Who cannot join
- Being diagnosed with neuromuscular, juvenile or congenital scoliosis
- Having received surgical treatment for scoliosis
- Rheumatological disease
- Having received treatment for TMJ dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Dentistry Faculty
Istanbul, Fatih, 34000
About this study
From the anatomical and functional point of view, stomatognathic system and spine have close connections. Together with the complex neuromuscular relationships, this creates an important area of cooperation between dentists and orthopedics (1). The cause of scoliosis has not been precisely explained, and various causes have been suggested in the literature, such as deviation from the standard growth pattern, neuromuscular tissue changes, asymmetric growth of the trunk, changes in the sagittal configuration of the spine, and environmental factors. In addition, scoliosis may develop secondary to each of hereditary musculoskeletal disorders such as osteogenesis imperfecta, Marfan syndrome, Stickler syndrome, Ehlers-Danlos syndrome and muscular dystrophies.
Fonder et al. conducted case studies showing the relationship between dental occlusion and scoliosis (2). There are studies suggesting that temporomandibular joint (TMJ) diseases are observed more frequently with the effect of the head-neck muscle balance affected by scoliosis and the irregularities in the occlusion. At the same time, some studies have shown that patients with mandible changes (deviation, deflection, asymmetry…), which is one of the TMJ components, often have abnormal morphology in the cervical vertebrae (3). Ito G et al. They reported that body posture is closely related to the function of the head support system. The cervical spine and muscles play an important role in stabilizing the head posture and in the complex and various movements of the head (4).
Read more
There is no study in the literature comparing the severity of scoliosis and TMJ joint dysfunction radiologically and clinically.
In this study, TMJ of scoliosis patients was evaluated by ultrasonography and clinical examination; It was aimed to correlate the severity of scoliosis with joint dysfunction.
- Conditions
- Scoliosis Patients
- Being tested
- Ultrasonography
- Keywords
- Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
Ultrasonography Examination
| Study group | Role | What they receive |
|---|---|---|
| Scoliosis Patients | Not described Receives: Diagnostic Test: Ultrasonography | |
| Control Group | Not described Receives: Diagnostic Test: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Pain Scale
Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study
Measured: 7 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Oct 2020
- Primary completion3 Jan 2021
- Study completion3 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Scoliosis PatientsStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Yelken Kendirci, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592133
- Sponsor's protocol ID
- 2020/1
- Status last verified
- Apr 2021
- First submitted
- 13 Oct 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not
Publications
Saccucci M, Tettamanti L, Mummolo S, Polimeni A, Festa F, Tecco S. Scoliosis and dental occlusion: a review of the literature. Scoliosis. 2011 Jul 29;6:15. doi: 10.1186/1748-7161-6-15.
PubMed 21801357Tecco S, Festa F. Cervical spine curvature and craniofacial morphology in an adult Caucasian group: a multiple regression analysis. Eur J Orthod. 2007 Apr;29(2):204-9. doi: 10.1093/ejo/cjl061. Epub 2007 Jan 11.
PubMed 17218718Ito, G., & Yamazaki, K. (1995). Relation between posture and the maxillofacial cranium. Jpn Dent Assoc, 48, 15-26.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Temporomandibular Joint Pathologies in Scoliosis Patients With Ultrasonography and Clinical Examination
- ClinicalTrials.gov ID
- NCT04592133
- Acronym / sponsor ID
- 2020/1
- Conditions
- Scoliosis Patients
- Keywords
- Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 3 Jan 2021 (actual)
- Study completion
- 3 Jan 2021 (actual)
- First posted
- 19 Oct 2020 (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.
From the anatomical and functional point of view, stomatognathic system and spine have close connections. Together with the complex neuromuscular relationships, this creates an important area of cooperation between dentists and orthopedics (1). The cause of scoliosis has not been precisely explained, and various causes have been suggested in the literature, such as deviation from the standard growth pattern, neuromuscular tissue changes, asymmetric growth of the trunk, changes in the sagittal configuration of the spine, and environmental factors. In addition, scoliosis may develop secondary to each of hereditary musculoskeletal disorders such as osteogenesis imperfecta, Marfan syndrome, Stickler syndrome, Ehlers-Danlos syndrome and muscular dystrophies.
Fonder et al. conducted case studies showing the relationship between dental occlusion and scoliosis (2). There are studies suggesting that temporomandibular joint (TMJ) diseases are observed more frequently with the effect of the head-neck muscle balance affected by scoliosis and the irregularities in the occlusion. At the same time, some studies have shown that patients with mandible changes (deviation, deflection, asymmetry…), which is one of the TMJ components, often have abnormal morphology in the cervical vertebrae (3). Ito G et al. They reported that body posture is closely related to the function of the head support system. The cervical spine and muscles play an important role in stabilizing the head posture and in the complex and various movements of the head (4).
There is no study in the literature comparing the severity of scoliosis and TMJ joint dysfunction radiologically and clinically.
In this study, TMJ of scoliosis patients was evaluated by ultrasonography and clinical examination; It was aimed to correlate the severity of scoliosis with joint dysfunction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scoliosis Patients | – | Diagnostic Test: Ultrasonography |
| Control Group | – | Diagnostic Test: Ultrasonography |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- All patient population admitted to our clinic
Key inclusion criteria (2 listed)
- Being between the ages of 12-18
- Being diagnosed with Adolescent Idiopathic Scoliosis
Key exclusion criteria (4 listed)
- Being diagnosed with neuromuscular, juvenile or congenital scoliosis
- Having received surgical treatment for scoliosis
- Rheumatological disease
- Having received treatment for TMJ dysfunction
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 |
|---|---|---|
| UltrasonographyUltrasonography Examination | Diagnostic test | Control Group, Scoliosis Patients |
Primary outcome
Joint Pain Scale
Time frame: 7 month
Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study
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 13 Apr 2021.
- Background: PubMed 21801357Saccucci M, Tettamanti L, Mummolo S, Polimeni A, Festa F, Tecco S. Scoliosis and dental occlusion: a review of the literature. Scoliosis. 2011 Jul 29;6:15. doi: 10.1186/1748-7161-6-15.
- Background: PubMed 17218718Tecco S, Festa F. Cervical spine curvature and craniofacial morphology in an adult Caucasian group: a multiple regression analysis. Eur J Orthod. 2007 Apr;29(2):204-9. doi: 10.1093/ejo/cjl061. Epub 2007 Jan 11.
- BackgroundIto, G., & Yamazaki, K. (1995). Relation between posture and the maxillofacial cranium. Jpn Dent Assoc, 48, 15-26.
- Joint, J. (2010). TMJ. Association. TMJ diseases and disorders: Basics-overview.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Not
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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 Scoliosis Patients, run by Istanbul 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 4 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 13 Apr 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?
Joint Pain Scale (time frame: 7 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04592133, which also lists 3 linked publications.
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 13 Apr 2021.