Temporomandibular Disorder (TMD)NCT07306936
Computer Guided Single Needle Arthrocentesis
A study testing Computer-guided single needle arthrocentesis and conventional free hand single needle arthrocentesis in people with Temporomandibular Disorder (TMD) and Internal Derangement, run by Alexandria University at 1 site in Egypt.
Trial summary
The intra-articular injection is considered the first line of minimally invasive treatment in temporomandibular joint with internal derangement (TMJ-ID) patients who do not respond to conservative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorder (TMD), Internal Derangement, Anterior Disc Displacement
- What is being tested?
- Computer-guided single needle arthrocentesis and conventional free hand single needle arthrocentesis
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients diagnosed with internal derangement according to Wilkes stage I and II.
- Adult patients above 18 years old.
- Patients who would not respond to conservative treatment as a first line of treatment
Who cannot join
- Patients with Wilkes stage III, IV, V.
- Patients suffering from any systemic diseases, platelets function disorders, fibrinogen deficiency.
- History of mandibular fracture.
- Lactating, pregnant or planning pregnancy women.
- Patients receiving anticoagulation treatment or NSAIDS within 48 hours preoperatively, corticosteroid injection at treatment site within 1 month or systemic use of corticosteroids within 2 weeks.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinics of Faculty of Dentistry, Alexandria University, Egypt Alexandria
Alexandria, Alexandria Governorate, 21523
About this study
Official title: Computer Guided Single Needle Arthrocentesis With Platelets Rich Plasma Injection in the Management of Temporomandibular Joint Internal Derangement
The intra-articular injection is considered the first line of minimally invasive treatment in temporomandibular joint with internal derangement (TMJ-ID) patients who do not respond to conservative treatment. The single-needle technique arthrocentesis has emerged to add reliability, convenience, ease the performance of the procedure, and eliminate the need for multiple punctures the Aim of this study is to assess clinical applicability and therapeutic outcomes of computer guided single needle arthrocentesis with platelet rich plasma using Shepard's cannula, in comparison with conventional free-hand technique, in the management of disc displacement with reduction of the TMJ.
Read the detailed description
A total of 24 patients with a magnetic resonance imaging (MRI) diagnosis of reducing disc displacement will be included and assigned randomly into one of two groups. Computer-guided arthrocentesis with PRP will be performed on patients in the study group using the single needle technique by Shepard cannula technique; while the conventional free hand technique will be performed in the control group. Procedure-related parameters will be assessed, while Clinical evaluation will be conducted on day 1, 1 and 3 months postoperatively.
- Being tested
- Computer-guided single needle arthrocentesis, conventional free hand single needle arthrocentesis
- Keywords
- temporomandibular disorder, intra-articular injection, internal derangement, anterior disc displacement, computer-assisted, Computer-aided design, computer-aided manufacturing, software, shepard cannula
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-guided single needle arthrocentesisDevice
Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis in adjunct to PRP intra-articular injection
conventional free hand single needle arthrocentesisDevice
Patients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis in adjunct to PRP intra-articular injection.
| Study group | Role | What they receive |
|---|---|---|
| Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis | Experimental | Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis in adjunct to PRP intra-articular injection. Receives: Device: Computer-guided single needle arthrocentesis |
| Patients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis | Placebo comparator | Patients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis in adjunct to PRP intra-articular injection Receives: Device: conventional free hand single needle arthrocentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective assessment of joint function and mandibular excursion
Clinical evaluation will be based on the Helkimo's clinical dysfunction index (Di), which is a part of the Helkimo index that provides an objective assesment of joint function and mandibular excursion.
All patients will be assessed immediately post-operative, 1 and 3 months. Postoperative clinical evaluation values will be compared to the preoperative baseline preoperative values.
Measured: 3 months
Secondary outcomes (1)
Duration of the Operation
Total procedural time consumed starting from the application of topical antiseptic up to the end of the procedure will be measured and compared between both groups. In the Computer-Guided group, the time for needle injection will be further computed to determine the actual injection time in the procedure bar from the guide installation time and patient preparation.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Apr 2025
- Primary completion30 Nov 2025
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorder (TMD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yehia El-Mahallawy, Phd, Principal investigator, Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306936
- Sponsor's protocol ID
- 12-12-25-RE-Shepared
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Guided Single Needle Arthrocentesis With Platelets Rich Plasma Injection in the Management of Temporomandibular Joint Internal Derangement
- ClinicalTrials.gov ID
- NCT07306936
- Acronym / sponsor ID
- 12-12-25-RE-Shepared
- Keywords
- temporomandibular disorder, intra-articular injection, internal derangement, anterior disc displacement, computer-assisted, Computer-aided design, computer-aided manufacturing, software
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 29 Dec 2025 (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 intra-articular injection is considered the first line of minimally invasive treatment in temporomandibular joint with internal derangement (TMJ-ID) patients who do not respond to conservative treatment. The single-needle technique arthrocentesis has emerged to add reliability, convenience, ease the performance of the procedure, and eliminate the need for multiple punctures the Aim of this study is to assess clinical applicability and therapeutic outcomes of computer guided single needle arthrocentesis with platelet rich plasma using Shepard's cannula, in comparison with conventional free-hand technique, in the management of disc displacement with reduction of the TMJ.
Detailed description
A total of 24 patients with a magnetic resonance imaging (MRI) diagnosis of reducing disc displacement will be included and assigned randomly into one of two groups. Computer-guided arthrocentesis with PRP will be performed on patients in the study group using the single needle technique by Shepard cannula technique; while the conventional free hand technique will be performed in the control group. Procedure-related parameters will be assessed, while Clinical evaluation will be conducted on day 1, 1 and 3 months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis | Experimental | Device: Computer-guided single needle arthrocentesisPatients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis in adjunct to PRP intra-articular injection. |
| Patients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis | Placebo comparator | Device: conventional free hand single needle arthrocentesisPatients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis in adjunct to PRP intra-articular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with internal derangement according to Wilkes stage I and II.
- Adult patients above 18 years old.
- Patients who would not respond to conservative treatment as a first line of treatment
Key exclusion criteria (5 listed)
- Patients with Wilkes stage III, IV, V.
- Patients suffering from any systemic diseases, platelets function disorders, fibrinogen deficiency.
- History of mandibular fracture.
- Lactating, pregnant or planning pregnancy women.
- Patients receiving anticoagulation treatment or NSAIDS within 48 hours preoperatively, corticosteroid injection at treatment site within 1 month or systemic use of corticosteroids within 2 weeks.
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 |
|---|---|---|
| Computer-guided single needle arthrocentesisPatients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis in adjunct to PRP intra-articular injection | Device | Patients with TMJ ID + reduction managed with computer-guided single needle arthrocentesis |
| conventional free hand single needle arthrocentesisPatients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis in adjunct to PRP intra-articular injection. | Device | Patients with TMJ ID + reduction managed with conventional free hand single needle arthrocentesis |
Primary outcome
objective assessment of joint function and mandibular excursion
Time frame: 3 months
Clinical evaluation will be based on the Helkimo's clinical dysfunction index (Di), which is a part of the Helkimo index that provides an objective assesment of joint function and mandibular excursion. All patients will be assessed immediately post-operative, 1 and 3 months. Postoperative clinical evaluation values will be compared to the preoperative baseline preoperative values.
1 secondary outcome
Duration of the Operation
Time frame: intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No. all data will be de-identified to protect the participant data. patients signed an informed consent for the use of their medical records and data for study
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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.
yehia El-Mahallawy, Phd principal investigator
Faculty of Dentistry, Alexandria University, Alexandria, Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-guided single needle arthrocentesis and conventional free hand single needle arthrocentesis in people with Temporomandibular Disorder (TMD) and Internal Derangement, run by Alexandria 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 29 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
objective assessment of joint function and mandibular excursion (time frame: 3 months). 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 29 Dec 2025.