Styloid-Stylohoid SyndromeNCT04280107
Evaluation of Styloid Chain Calcification to the Patient With the Temporomandibular Joint Disorder
An observational study of Styloid-Stylohoid Syndrome and Temporomandibular Disorder, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to evaluate any relation between elongated styloid process (ESP) and type of Temporomandibular Joint Disorders (TMD). Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Styloid-Stylohoid Syndrome, Temporomandibular Disorder
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2018to 4 Dec 2019
- 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 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients have at least one of these clinic conditions: TMJ pain, mouth opening restriction, joint sound, joint function disorder.
Who may be able to join
- Clinical Diagnosis of Temporomandibular Dysfunction(TMD)
- TMD patients with MR and CBCT images recorded in the digital archive.
Who cannot join
- operated or treated for any Temporomandibular Joint Diseases
- head and neck trauma
- orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nuh Naci Yazgan University
Kayseri, Kocasinan, 38170
About this study
Official title: 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).
Read the 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.
- Keywords
- magnetic resonance imaging, cone beam computed tomography, temporomandibular dysfunction, Styloid-Stylohoid Syndrome
- Medical subject headings
- Eagle syndrome, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Styloid chain calsifiaction pattern
Interpretation of Styloid chain calsifiaction pattern on reconstructed sagittal slices of CBCT.
Measured: 2 months
Styloid processes length
Styloid processes length measured linearly on reconstructed sagittal slices of CBCT.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start12 Dec 2018
- Primary completion20 Oct 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Styloid-Stylohoid SyndromeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuh Naci Yazgan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Cansu Kış, Nuh Naci Yazgan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280107
- Sponsor's protocol ID
- 2018-615
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32632703
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Styloid Chain Calcification to the Patient With the Temporomandibular Joint Disorder: a Retrospective Uncontrolled Cohort Study
- ClinicalTrials.gov ID
- NCT04280107
- Acronym / sponsor ID
- 2018-615
- Keywords
- magnetic resonance imaging, cone beam computed tomography, temporomandibular dysfunction, Styloid-Stylohoid Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Nuh Naci Yazgan UniversityUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 21 Feb 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.
The aim of the study was to evaluate any relation between elongated styloid process (ESP) and type of Temporomandibular Joint Disorders (TMD).
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients have at least one of these clinic conditions: TMJ pain, mouth opening restriction, joint sound, joint function disorder.
Key inclusion criteria (2 listed)
- Clinical Diagnosis of Temporomandibular Dysfunction(TMD)
- TMD patients with MR and CBCT images recorded in the digital archive.
Key exclusion criteria (3 listed)
- operated or treated for any Temporomandibular Joint Diseases
- head and neck trauma
- orthodontic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Styloid chain calsifiaction pattern
Time frame: 2 months
Interpretation of Styloid chain calsifiaction pattern on reconstructed sagittal slices of CBCT.
Styloid processes length
Time frame: 2 months
Styloid processes length measured linearly on reconstructed sagittal slices of CBCT.
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 25 Feb 2020.
- Derived from this study: PubMed 32632703Kis 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.
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 Styloid-Stylohoid Syndrome and Temporomandibular Disorder, run by Nuh Naci Yazgan 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 3 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 25 Feb 2020. 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?
Styloid chain calsifiaction pattern (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT04280107, which also lists 1 linked publication.
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 25 Feb 2020.