Device ReliabilityNCT04452110
Investigation of the Reliability of Ultrasonography Usage in the Diagnosis of Temporomandibular Joint Diseases
An observational study of Device Reliability, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, temporomandibular joint diseases on the diagnostic value of the use of ultrasonography in diagnosis studies are lacking. In this study in the diagnosis of temporomandibular joint diseases revealing the reliability of the use of ultrasonography. It is aimed to contribute to the literature in terms of. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Device Reliability
- What is being tested?
- Ultrasonography
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2019to 31 Dec 2020
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients Applying to Our University
Who may be able to join
- Patients over the age of 18 who apply with TMJ problems
- Patients with pain in the joint and chewing muscle area
Who cannot join
- Syndromic patients
- Patients under the age of 18
- Patients with a history of orthognathic surgery
- Pregnants
- Antidepressant Users
- Patients Using Removable Dentures
- Patients who have had joint treatment in the past six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Dentistry Faculty
Istanbul, Fatih, 34200
About this study
Official title: Investigation of the Reliability of Ultrasonography Usage in the Diagnosis of Temporomandibular Joint Diseases: A Prospective Study
In the literature, temporomandibular joint diseases on the diagnostic value of the use of ultrasonography in diagnosis studies are lacking. In this study in the diagnosis of temporomandibular joint diseases revealing the reliability of the use of ultrasonography. It is aimed to contribute to the literature in terms of.
- Conditions
- Device Reliability
- Being tested
- Ultrasonography
- Keywords
- Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
Temporomandibular joint diseases of ultrasonography its effectiveness and reliability in diagnosis disadvantages in MR and other imaging methods be ruled out.
| Study group | Role | What they receive |
|---|---|---|
| Group I | In volunteers in Group 1, values obtained using a linear probe will be compared. Receives: Diagnostic Test: Ultrasonography | |
| Group II | In volunteers in Group 2, values obtained using a hockey stick probe will be compared. Receives: Diagnostic Test: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Pain Scale
Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start21 Nov 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 Device ReliabilityStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Faruk ERTURK, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452110
- Sponsor's protocol ID
- 2019/73
- Other IDs
- 34908, 2019-188
- Status last verified
- Apr 2021
- First submitted
- 23 Jun 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Erturk AF, Yelken Kendirci M, Ozcan I, Gokcen Rohlig B. Use of ultrasonography in the diagnosis of temporomandibular disorders: a prospective clinical study. Oral Radiol. 2023 Apr;39(2):282-291. doi: 10.1007/s11282-022-00635-w. Epub 2022 Aug 3.
PubMed 35920968
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Reliability of Ultrasonography Usage in the Diagnosis of Temporomandibular Joint Diseases: A Prospective Study
- ClinicalTrials.gov ID
- NCT04452110
- Acronym / sponsor ID
- 2019/73
- Conditions
- Device Reliability
- Keywords
- Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Jun 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.
In the literature, temporomandibular joint diseases on the diagnostic value of the use of ultrasonography in diagnosis studies are lacking. In this study in the diagnosis of temporomandibular joint diseases revealing the reliability of the use of ultrasonography. It is aimed to contribute to the literature in terms of.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Diagnostic Test: UltrasonographyIn volunteers in Group 1, values obtained using a linear probe will be compared. |
| Group II | – | Diagnostic Test: UltrasonographyIn volunteers in Group 2, values obtained using a hockey stick probe will be compared. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Applying to Our University
Key inclusion criteria (2 listed)
- Patients over the age of 18 who apply with TMJ problems
- Patients with pain in the joint and chewing muscle area
Key exclusion criteria (7 listed)
- Syndromic patients
- Patients under the age of 18
- Patients with a history of orthognathic surgery
- Pregnants
- Antidepressant Users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyTemporomandibular joint diseases of ultrasonography its effectiveness and reliability in diagnosis disadvantages in MR and other imaging methods be ruled out. | Diagnostic test | Group I, Group II |
Primary outcome
Joint Pain Scale
Time frame: 1 year
Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study
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 13 Apr 2021.
- Derived from this study: PubMed 35920968Erturk AF, Yelken Kendirci M, Ozcan I, Gokcen Rohlig B. Use of ultrasonography in the diagnosis of temporomandibular disorders: a prospective clinical study. Oral Radiol. 2023 Apr;39(2):282-291. doi: 10.1007/s11282-022-00635-w. Epub 2022 Aug 3.
- Individual participant dataSharing planned: Undecided
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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 Device Reliability, run by Istanbul 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 7 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 13 Apr 2021. 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?
Joint Pain Scale (time frame: 1 year). 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 NCT04452110, 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 13 Apr 2021.