Prospective Evaluation of Temporomandibular Joint Patholo... | NCT04592133

Studies
Prospective Evaluation of Temporomandibular Joint Pathologies in Scoliosis Patients With Ultrasonography and Clinical Examination

NCT04592133

Sponsor

Istanbul University

Status

Completed

Last Update Posted

Apr 13, 2021Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Scoliosis Patients

Interventions

Ultrasonography

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2020Actual

Primary Completion Date

Jan 3, 2021Actual

Completion Date

Jan 3, 2021Actual

First Submitted Date

Oct 13, 2020

First Submission Date that Met QC Criteria

Oct 16, 2020

First Posted Date

Oct 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2021

Last Update Posted Date

Apr 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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). 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Scoliosis Patients			Diagnostic Test: Ultrasonography
Control Group			Diagnostic Test: Ultrasonography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonography	Diagnostic Test	Ultrasonography Examination	Control Group Scoliosis Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Joint Pain Scale	Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study	7 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being between the ages of 12-18
Being diagnosed with Adolescent Idiopathic Scoliosis

Exclusion Criteria:

Being diagnosed with neuromuscular, juvenile or congenital scoliosis
Having received surgical treatment for scoliosis
Rheumatological disease
Having received treatment for TMJ dysfunction

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

All patient population admitted to our clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul University Dentistry Faculty		Istanbul	Fatih	34000	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21801357	Background	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.
17218718	Background	Tecco 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.

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis