NCT04280107

Brief Summary

The aim of the study was to evaluate any relation between elongated styloid process (ESP) and type of Temporomandibular Joint Disorders (TMD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

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

December 12, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

February 20, 2020

Last Update Submit

February 21, 2020

Conditions

Keywords

magnetic resonance imagingcone beam computed tomographytemporomandibular dysfunctionStyloid-Stylohoid Syndrome

Outcome Measures

Primary Outcomes (2)

  • Styloid chain calsifiaction pattern

    Interpretation of Styloid chain calsifiaction pattern on reconstructed sagittal slices of CBCT.

    2 months

  • Styloid processes length

    Styloid processes length measured linearly on reconstructed sagittal slices of CBCT.

    2 months

Study Arms (1)

Temporomandibular Dysfunction

For this study, 154 patient files who were admitted to the radiology department of the faculty of dentistry between 2013 and 2019 with complaints such as TMJ pain, mouth opening restriction, joint sound, joint function disorder were scanned retrospectively. Inclusion criteria: TMD patients with MR and CBCT images recorded in the digital archive. Exclusion criteria: Patients who have been operated or treated from TMJ, patients with head and neck trauma, patients with orthodontic treatment.

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients have at least one of these clinic conditions: TMJ pain, mouth opening restriction, joint sound, joint function disorder.

You may qualify if:

  • Clinical Diagnosis of Temporomandibular Dysfunction(TMD)
  • TMD patients with MR and CBCT images recorded in the digital archive.

You may not qualify if:

  • operated or treated for any Temporomandibular Joint Diseases
  • head and neck trauma
  • orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuh Naci Yazgan University

Kayseri, Kocasinan, 38170, Turkey (Türkiye)

Location

Related Publications (1)

  • Kis HC, Soydan Cabuk D. Evaluation of styloid chain calcification related to temporomandibular joint disc displacement: a retrospective cohort study. Oral Radiol. 2021 Jul;37(3):395-402. doi: 10.1007/s11282-020-00463-w. Epub 2020 Jul 6.

MeSH Terms

Conditions

Eagle syndromeTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 21, 2020

Study Start

December 12, 2018

Primary Completion

October 20, 2019

Study Completion

December 4, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations