TMJ Disc DisorderNCT04942743
Clinical & MRI Finding of TMJ Disk Perforation
An observational study of TMJ Disc Disorder, run by Al-Azhar University at 1 site in Egypt.
Trial summary
the study aimed to evaluate the clinical and MRI finding of TMJ with disk perforation with predication of the risk factors. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- MRI
- How many people
- 900 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2020to 15 Jun 2021
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The sample originally included patients who provided consent to participate in this study and who ultimately underwent treatment for TMJD between 2008 and 2019.
Who may be able to join
- patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University.
Who cannot join
- Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous fibrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine Alazhar University
Cairo, Nasr City, 11765
About this study
the study aimed to evaluate the clinical and MRI finding of TMJ with disk perforation with predication of the risk factors.
Read the detailed description
The retrospective study included patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University. The sample originally included patients who provided consent to participate in this study and who ultimately underwent treatment for TMJD between 2008 and 2019.
Exclusion Inclusion criteria: Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous fibrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.
the study included 2 groups group 1: normal TMJ patients group 2: patients with TMJ internal derangement
- Conditions
- TMJ Disc Disorder
- Being tested
- MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI OF TMJ
| Study group | Role | What they receive |
|---|---|---|
| control group | patients with normal TMJ Receives: Diagnostic Test: MRI | |
| Study group | patients with TMJ internal derangement Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
joint pain (VAS),
pain index scores were measured using a 10-point visual analogue scale (VAS), with 0 indicating absence of pain and 10 indicating the worst pain.
Measured: pre treatment
(MVMO)
mouth opening
Measured: pretreatment
Secondary outcomes (1)
joint sound
joint sound was then determined by combining 3 means: (1) palpation of the TMJ zone by the clinician, (2) the patient's self-reporting regarding whether the joint sound could be heard, and (3) auscultation of the TMJ zone with the stethoscope.
Measured: pretreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start12 Jan 2020
- Primary completion31 Dec 2020
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Disc DisorderStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Hegab, Al-Azhar University
- Investigators
- Ayman Hegab, Phd, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942743
- Sponsor's protocol ID
- AUAREC20200501-12
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical & MRI Finding of TMJ Disk Perforation
- ClinicalTrials.gov ID
- NCT04942743
- Acronym / sponsor ID
- AUAREC20200501-12
- Conditions
- TMJ Disc Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 28 Jun 2021 (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 study aimed to evaluate the clinical and MRI finding of TMJ with disk perforation with predication of the risk factors.
Detailed description
The retrospective study included patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University. The sample originally included patients who provided consent to participate in this study and who ultimately underwent treatment for TMJD between 2008 and 2019.
Exclusion Inclusion criteria: Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous fibrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.
the study included 2 groups group 1: normal TMJ patients group 2: patients with TMJ internal derangement
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Diagnostic Test: MRIpatients with normal TMJ |
| Study group | – | Diagnostic Test: MRIpatients with TMJ internal derangement |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample originally included patients who provided consent to participate in this study and who ultimately underwent treatment for TMJD between 2008 and 2019.
Key inclusion criteria (1 listed)
- patients seeking treatment for TMD at Al-Azhar University Hospital and the outpatient clinic at the Faculty of Dental Medicine of Al-Azahr University.
Key exclusion criteria (1 listed)
- Patients were included if they were older than 18 years and diagnosed with TMJD. criteria for this study included systemic diseases (the presence of polyarthritis or other rheumatic diseases), contraindications for MRI (e.g., implanted metal or medical devices, claustrophobia), the presence of neurologic disorders, head and neck cancer, oral submucous fibrosis, a history of TMJ surgery, a history of previous nonsurgical treatment such as occlusal splints, and a history of joint injection with HA/PRP. Trauma patients with subcondylar fracture and patients with congenital and developmental disorders of the TMJ were also excluded from the study.
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 |
|---|---|---|
| MRIMRI OF TMJ | Diagnostic test | Study group, control group |
Primary outcome
joint pain (VAS),
Time frame: pre treatment
pain index scores were measured using a 10-point visual analogue scale (VAS), with 0 indicating absence of pain and 10 indicating the worst pain.
(MVMO)
Time frame: pretreatment
mouth opening
1 secondary outcome
joint sound
Time frame: pretreatment
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 1 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Ayman Hegab, Phd principal investigator
Al-Azhar University
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 TMJ Disc Disorder, run by Al-Azhar University at 1 site in Egypt.
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 1 inclusion and 1 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 1 Jul 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 Egypt. 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 (VAS), (time frame: pre treatment). 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?
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 1 Jul 2021.