TMDNCT05522114
Accuracy of Patient Specific Guide for TMJ Injection
A study testing TMJ injection using patient specific guide in people with TMD, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study is designed to evaluate the accuracy of planned needle position using patient specific guide during TMJ superior joint space injection. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- TMD
- What is being tested?
- TMJ injection using patient specific guide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Apr 2022to 22 Aug 2022
- Phase
- Interventional
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- Patients who would not respond to conservative treatment as the first line of treatment.
Who cannot join
- Lactating, pregnant or planning pregnancy women.
- Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Patient Specific Guide Accuracy for TMJ Superior Joint Space Injection.
This study is designed to evaluate the accuracy of planned needle position using patient specific guide during TMJ superior joint space injection.
Read the detailed description
The actual position of the needle evaluated in comparison to the planned one using MSCT while the patient wearing the customized needle guide.
- Conditions
- TMD
- Being tested
- TMJ injection using patient specific guide
- Keywords
- virtual planning, 3D printing, TMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMJ injection using patient specific guideProcedure or surgery
Prefabricated patient specific guide used to guide the needle into the superior joint space of TMJ while real time MSCT evaluate the accuracy of needle position. Sodium hyaloronate injected within the superior joint space.
| Study group | Role | What they receive |
|---|---|---|
| Patient specific guided injection | Experimental | Patients treated with HA injection in TMJ using PSG and the accuracy evaluated using MSCT. Receives: Procedure: TMJ injection using patient specific guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle of deviation
The angle (°) between the planned and actual needle measured.
Measured: 1 month
Vertical displacement of needle tip
The vertical displacement of the actual needle tip in comparison to the planned one (mm).
Measured: 1 month
Overall needle tip dislocation
The distance between the planned and actual needle tips (mm).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start19 Apr 2022
- Primary completion3 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKader Ahmed Hyder Mohamed, Al-Azhar University
- Investigators
- AbdElKader A Hyder, MSc, Principal investigator, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar UniversityWael A ElMohandes, PhD, Study director, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar UniversityBahaa El-Din A Tawfik, PhD, Study director, Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522114
- Sponsor's protocol ID
- PSG-TMJ-acc.
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Specific Guide Accuracy for TMJ Superior Joint Space Injection.
- ClinicalTrials.gov ID
- NCT05522114
- Acronym / sponsor ID
- PSG-TMJ-acc.
- Conditions
- TMD
- Keywords
- virtual planning, 3D printing, TMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 30 Aug 2022 (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.
This study is designed to evaluate the accuracy of planned needle position using patient specific guide during TMJ superior joint space injection.
Detailed description
The actual position of the needle evaluated in comparison to the planned one using MSCT while the patient wearing the customized needle guide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient specific guided injection | Experimental | Procedure: TMJ injection using patient specific guidePatients treated with HA injection in TMJ using PSG and the accuracy evaluated using MSCT. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed with intra-articular TMJ disorder according to Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
- Patients who would not respond to conservative treatment as the first line of treatment.
Key exclusion criteria (2 listed)
- Lactating, pregnant or planning pregnancy women.
- Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
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 |
|---|---|---|
| TMJ injection using patient specific guidePrefabricated patient specific guide used to guide the needle into the superior joint space of TMJ while real time MSCT evaluate the accuracy of needle position. Sodium hyaloronate injected within the superior joint space. | Procedure or surgery | Patient specific guided injection |
Primary outcome
Angle of deviation
Time frame: 1 month
The angle (°) between the planned and actual needle measured.
Vertical displacement of needle tip
Time frame: 1 month
The vertical displacement of the actual needle tip in comparison to the planned one (mm).
Overall needle tip dislocation
Time frame: 1 month
The distance between the planned and actual needle tips (mm).
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 30 Aug 2022.
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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.
AbdElKader A Hyder, MSc principal investigator
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
Wael A ElMohandes, PhD study director
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
Bahaa El-Din A Tawfik, PhD study director
Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMJ injection using patient specific guide in people with TMD, 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 2 inclusion and 2 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 30 Aug 2022. 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?
Angle of deviation (time frame: 1 month). The study lists 3 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 30 Aug 2022.