ArthroscopeNCT07316790
Evaluation Study of Retro Discal Tissue Injection Arthroscopically Versus Ultrasound Guide Injection
A study testing Arthroscopic retrodiscal tissue injection and Ultrasound-guided retrodiscal tissue injection in people with Arthroscope, run by Cairo University at 1 site in Egypt.
Trial summary
A comparative evaluation study of arthroscopic retrodiscal tissue injection versus ultrasound-guided injection in temporomandibular joint disorders aims to assess differences in pain relief, functional improvement, and clinical outcomes between an invasive and a minimally invasive delivery technique. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroscope
- What is being tested?
- Arthroscopic retrodiscal tissue injection and Ultrasound-guided retrodiscal tissue injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Dec 2025to 30 Jun 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adults aged 18-60 years with symptomatic TMJ disorder/internal derangement (unilateral or bilateral)
- TMJ pain at rest and/or during function for ≥ 3 months
- Clinical diagnosis consistent with disc displacement with or without reduction (with or without MRI confirmation, if included in the protocol)
- Baseline pain intensity ≥ 4/10 on VAS or NRS
- Limitation of mouth opening or functional impairment (e.g., maximum mouth opening ≤ 35 mm or pain-related limitation)
- Failed or insufficient response to conservative therapy for ≥ 4-6 weeks (e.g., soft diet, NSAIDs, splint therapy, physiotherapy)
- Ability to provide informed consent and comply with scheduled follow-up visits
Who cannot join
- Previous TMJ surgery (arthroscopy or arthrotomy) on the study side or TMJ injection within the last 3-6 months
- TMJ ankylosis, fracture, tumor, or active infection
- Primary inflammatory arthropathy (e.g., rheumatoid arthritis, gout, psoriatic arthritis) or systemic connective tissue disease affecting the TMJ
- Significant degenerative joint disease (advanced osteoarthritis) if the study focuses on internal derangement or soft tissue pathology
- Severe skeletal or dentofacial deformity requiring orthognathic surgery during the study period
- Pregnancy or lactation
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- Bleeding disorders, platelet disorders, or anticoagulant therapy that cannot be safely managed (particularly relevant for PRP injections)
- Known allergy or contraindication to the planned injectate or local anesthetic
- Severe uncontrolled systemic disease (ASA III-IV) or inability to tolerate anesthesia or sedation (for arthroscopy arm)
- Active psychiatric or neurologic condition that may impair accurate pain reporting or follow-up compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Evaluation Study of Retro Discal Tissue Injection Arthroscopically Versus Ultrasound Guide Injection
A comparative evaluation study of arthroscopic retrodiscal tissue injection versus ultrasound-guided injection in temporomandibular joint disorders aims to assess differences in pain relief, functional improvement, and clinical outcomes between an invasive and a minimally invasive delivery technique. Arthroscopic injection allows direct visualization of intra-articular structures, accurate targeting of the retrodiscal tissues, and simultaneous management of associated pathology such as synovitis or adhesions, which may enhance therapeutic outcomes in advanced internal derangement. In contrast, ultrasound-guided injection offers a less invasive, cost-effective, and outpatient-based approach with improved accuracy over blind techniques, making it suitable for early or moderate cases. While both methods are effective in reducing pain and improving mouth opening and jaw function, arthroscopic injection may provide superior results in patients requiring diagnostic confirmation and mechanical intervention, whereas ultrasound-guided injection offers comparable symptomatic improvement with lower procedural morbidity and resource utilization.
- Conditions
- Arthroscope
- Being tested
- Arthroscopic retrodiscal tissue injection, Ultrasound-guided retrodiscal tissue injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic retrodiscal tissue injectionProcedure or surgery
Arthroscopic retrodiscal tissue injection
Ultrasound-guided retrodiscal tissue injectionProcedure or surgery
Ultrasound-guided retrodiscal tissue injection
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Retrodiscal Tissue Injection | Experimental | Arthroscopic Retrodiscal Tissue Injection Receives: Procedure: Arthroscopic retrodiscal tissue injection |
| Ultrasound-Guided Retrodiscal Tissue Injection | Active comparator | Ultrasound-Guided Retrodiscal Tissue Injection Receives: Procedure: Ultrasound-guided retrodiscal tissue injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (VAS)
Change in TMJ pain score measured on a 10-cm Visual Analogue Scale (0 = no pain, 10 = worst pain) from baseline to 3 months post-intervention.
Measured: Baseline → 2 months (early outcome) Baseline → 6 months (mid-term outcome)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start13 Dec 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ArthroscopeStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wajmah Sayed Karim Al Sayed, Cairo University
- Investigators
- Niveen AL Asker, Prof, Principal investigator, Cairo UniversityNiveen AL Asker, Prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316790
- Sponsor's protocol ID
- arthroscope versus ultrasound
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) generated during this study will be made available to other researchers upon reasonable request. The shared IPD will include baseline demographic data, clinical diagnosis, intervention allocation, pain scores (VAS), maximum mouth opening measurements, and follow-up outcome data at predefined time points. All shared data will be anonymized to ensure participant confidentiality, and no direct identifiers will be disclosed. Data will be available after publication of the primary study results and may be used for academic and non-commercial research purposes following approval by the study investigators.
Publications
Cha YH, O J, Park JK, Yang HM, Kim SH. Ultrasound-guided versus blind temporomandibular joint injections: a pilot cadaveric evaluation. Int J Oral Maxillofac Surg. 2019 Apr;48(4):540-545. doi: 10.1016/j.ijom.2018.09.002. Epub 2018 Oct 2.
PubMed 30287106Lopez JP, Orjuela MP, Gonzalez LV, Peraza-Labrador AJ, Diaz-Baez D. Comparison of the Clinical Effectiveness of Intra-Articular Injection with Different Substances After TMJ Arthroscopy: A Systematic Review and Meta-Analysis. J Maxillofac Oral Surg. 2024 Apr;23(2):261-270. doi: 10.1007/s12663-023-02047-7. Epub 2023 Dec 12.
PubMed 38601255
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation Study of Retro Discal Tissue Injection Arthroscopically Versus Ultrasound Guide Injection
- ClinicalTrials.gov ID
- NCT07316790
- Acronym / sponsor ID
- arthroscope versus ultrasound
- Conditions
- Arthroscope
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Dec 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 5 Jan 2026 (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.
A comparative evaluation study of arthroscopic retrodiscal tissue injection versus ultrasound-guided injection in temporomandibular joint disorders aims to assess differences in pain relief, functional improvement, and clinical outcomes between an invasive and a minimally invasive delivery technique. Arthroscopic injection allows direct visualization of intra-articular structures, accurate targeting of the retrodiscal tissues, and simultaneous management of associated pathology such as synovitis or adhesions, which may enhance therapeutic outcomes in advanced internal derangement. In contrast, ultrasound-guided injection offers a less invasive, cost-effective, and outpatient-based approach with improved accuracy over blind techniques, making it suitable for early or moderate cases. While both methods are effective in reducing pain and improving mouth opening and jaw function, arthroscopic injection may provide superior results in patients requiring diagnostic confirmation and mechanical intervention, whereas ultrasound-guided injection offers comparable symptomatic improvement with lower procedural morbidity and resource utilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Retrodiscal Tissue Injection | Experimental | Procedure: Arthroscopic retrodiscal tissue injectionArthroscopic Retrodiscal Tissue Injection |
| Ultrasound-Guided Retrodiscal Tissue Injection | Active comparator | Procedure: Ultrasound-guided retrodiscal tissue injectionUltrasound-Guided Retrodiscal Tissue Injection |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18-60 years with symptomatic TMJ disorder/internal derangement (unilateral or bilateral)
- TMJ pain at rest and/or during function for ≥ 3 months
- Clinical diagnosis consistent with disc displacement with or without reduction (with or without MRI confirmation, if included in the protocol)
- Baseline pain intensity ≥ 4/10 on VAS or NRS
- Limitation of mouth opening or functional impairment (e.g., maximum mouth opening ≤ 35 mm or pain-related limitation)
Key exclusion criteria (10 listed)
- Previous TMJ surgery (arthroscopy or arthrotomy) on the study side or TMJ injection within the last 3-6 months
- TMJ ankylosis, fracture, tumor, or active infection
- Primary inflammatory arthropathy (e.g., rheumatoid arthritis, gout, psoriatic arthritis) or systemic connective tissue disease affecting the TMJ
- Significant degenerative joint disease (advanced osteoarthritis) if the study focuses on internal derangement or soft tissue pathology
- Severe skeletal or dentofacial deformity requiring orthognathic surgery during the study period
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 |
|---|---|---|
| Arthroscopic retrodiscal tissue injectionArthroscopic retrodiscal tissue injection | Procedure or surgery | Arthroscopic Retrodiscal Tissue Injection |
| Ultrasound-guided retrodiscal tissue injectionUltrasound-guided retrodiscal tissue injection | Procedure or surgery | Ultrasound-Guided Retrodiscal Tissue Injection |
Primary outcome
Pain intensity (VAS)
Time frame: Baseline → 2 months (early outcome) Baseline → 6 months (mid-term outcome)
Change in TMJ pain score measured on a 10-cm Visual Analogue Scale (0 = no pain, 10 = worst pain) from baseline to 3 months post-intervention.
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 5 Jan 2026.
- Results publication: PubMed 30287106Cha YH, O J, Park JK, Yang HM, Kim SH. Ultrasound-guided versus blind temporomandibular joint injections: a pilot cadaveric evaluation. Int J Oral Maxillofac Surg. 2019 Apr;48(4):540-545. doi: 10.1016/j.ijom.2018.09.002. Epub 2018 Oct 2.
- Results publication: PubMed 38601255Lopez JP, Orjuela MP, Gonzalez LV, Peraza-Labrador AJ, Diaz-Baez D. Comparison of the Clinical Effectiveness of Intra-Articular Injection with Different Substances After TMJ Arthroscopy: A Systematic Review and Meta-Analysis. J Maxillofac Oral Surg. 2024 Apr;23(2):261-270. doi: 10.1007/s12663-023-02047-7. Epub 2023 Dec 12.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) generated during this study will be made available to other researchers upon reasonable request. The shared IPD will include baseline demographic data, clinical diagnosis, intervention allocation, pain scores (VAS), maximum mouth opening measurements, and follow-up outcome data at predefined time points. All shared data will be anonymized to ensure participant confidentiality, and no direct identifiers will be disclosed. Data will be available after publication of the primary study results and may be used for academic and non-commercial research purposes following approval by the study investigators.
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.
Niveen AL Asker, Prof principal investigator
Cairo University
Niveen AL Asker, Prof study director
Cairo 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 Arthroscopic retrodiscal tissue injection and Ultrasound-guided retrodiscal tissue injection in people with Arthroscope, run by Cairo 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 5 Jan 2026. 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?
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?
Contact wajmah SA Al Sayed, phd (0509560055, wajmah.sayed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (VAS) (time frame: Baseline → 2 months (early outcome) Baseline → 6 months (mid-term outcome)). 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 NCT07316790, which also lists 2 linked publications.
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 5 Jan 2026.