NCT04592133

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

October 13, 2020

Last Update Submit

April 9, 2021

Conditions

Keywords

Ultrasonography

Outcome Measures

Primary Outcomes (1)

  • Joint Pain Scale

    Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study

    7 month

Study Arms (2)

Scoliosis Patients

Diagnostic Test: Ultrasonography

Control Group

Diagnostic Test: Ultrasonography

Interventions

UltrasonographyDIAGNOSTIC_TEST

Ultrasonography Examination

Control GroupScoliosis Patients

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

All patient population admitted to our clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Dentistry Faculty

Istanbul, Fatih, 34000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 21801357BACKGROUND
  • 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.

    PMID: 17218718BACKGROUND
  • Ito, G., & Yamazaki, K. (1995). Relation between posture and the maxillofacial cranium. Jpn Dent Assoc, 48, 15-26.

    BACKGROUND

Related Links

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 19, 2020

Study Start

October 1, 2020

Primary Completion

January 3, 2021

Study Completion

January 3, 2021

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Not

Locations