- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04280107
Evaluation of Styloid Chain Calcification to the Patient With the Temporomandibular Joint Disorder
February 21, 2020 updated by: Hatice Cansu Kış, Nuh Naci Yazgan University
Evaluation of Styloid Chain Calcification to the Patient With the Temporomandibular Joint Disorder: a Retrospective Uncontrolled Cohort Study
The aim of the study was to evaluate any relation between elongated styloid process (ESP) and type of Temporomandibular Joint Disorders (TMD).
Study Overview
Status
Completed
Detailed Description
The styloid process (SP) of the temporal bone is a long conical cartilaginous projection lies anterior to the mastoid process.
Patients who have ESP or styloid chain calcification are usually asymptomatic, only 4% are symptomatic.
Symptoms vary as different syndromes which related affected anatomic structures by calcified process or ligament.
Temporomandibular Dysfunction (TMD) describe the temporomandibular joint (TMJ) disfunction that divided three branches according to temporomandibular joint's disc status: non-displacement (ND), displacement with reduction (DWR) and displacement without reduction (DWoR).
Since orofacial pain shows similar features in both ESP or styloid chain calcification and TMD, it is possible to confuse and misdiagnosis both of these clinical conditions.
This study aimed to investigate the length and calcification pattern of the styloid process in patients with TMD diagnosis.
Study Type
Observational
Enrollment (Actual)
47
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kocasinan
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Kayseri, Kocasinan, Turkey, 38170
- Nuh Naci Yazgan University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 81 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients have at least one of these clinic conditions: TMJ pain, mouth opening restriction, joint sound, joint function disorder.
Description
Inclusion Criteria:
- Clinical Diagnosis of Temporomandibular Dysfunction(TMD)
- TMD patients with MR and CBCT images recorded in the digital archive.
Exclusion Criteria:
- operated or treated for any Temporomandibular Joint Diseases
- head and neck trauma
- orthodontic treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Styloid chain calsifiaction pattern
Time Frame: 2 months
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Interpretation of Styloid chain calsifiaction pattern on reconstructed sagittal slices of CBCT.
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2 months
|
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Styloid processes length
Time Frame: 2 months
|
Styloid processes length measured linearly on reconstructed sagittal slices of CBCT.
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2 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 12, 2018
Primary Completion (ACTUAL)
October 20, 2019
Study Completion (ACTUAL)
December 4, 2019
Study Registration Dates
First Submitted
February 20, 2020
First Submitted That Met QC Criteria
February 20, 2020
First Posted (ACTUAL)
February 21, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 21, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-615
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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