TMJ Disc DisorderNCT07614932
Arthroscopic Lysis and Lavage With and Without Intra-articular Injection of Hyaluronic Acid in Patients With DDwoR in TMJ
A study testing Arthroscopic lysis and lavage and arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid in people with TMJ Disc Disorder and Temporomandibular Joint Disc Displacement, Without Reduction, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to assess the outcomes of arthroscopic lysis and lavage procedure with and without single intra-articular injection of hyaluronic acid in managing patients with anterior disc displacement without reduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TMJ Disc Disorder, Temporomandibular Joint Disc Displacement, Without Reduction, TMD/Orofacial Pain
- What is being tested?
- Arthroscopic lysis and lavage and arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- May 2026to Jan 2027
- 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
- Adults above 18 years old.
- Diagnosis of Disc Displacement Without Reduction (DDWOR) with limited mouth : eitherunilateral or bilateral based on the DC/TMD and confirmed with MRI
- History of unsuccessful conservative treatment such as physical therapy, occlusal splints,or medications (e.g., NSAIDs, muscle relaxants) for at least 3 months.
- Patients must sign the informed consent, understand the study procedures and potential risks, accept to volunteer in the study and be available to attend the follow-up visits.
Who cannot join
- Degenerative Temporomandibular Joint Disorders (e.g., osteoarthritis, rheumatoid arthritis).
- History of prior TMJ surgery (e.g., joint replacement, previous arthroscopy).
- Severe Systemic Conditions (e.g., cardiovascular disease, autoimmune disorders, uncontrolled diabetes).
- Active joint infection, acute inflammation, or presence of any condition that may increase the risk of complications from arthroscopic surgery or injections (e.g., local infection, uncontrolled bleeding disorders).
- Pregnancy or Breastfeeding.
- Patients with severe Psychological Conditions (e.g., severe depression, psychosis, myofascial pain disorder) or dental related pain will be identified at the initial assessment and referred for appropriate psychological, behavioural, or dental management prior to inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo
Eshraq Ahmed ElMetwally, +201287472001, eshraq.elmetwally@dentistry.cu.edu.eg
About this study
Official title: Assessment of Arthroscopic Lysis and Lavage With And Without Intra-Articular Injection of Hyaluronic Acid in the Management of Patients With Disc Displacement Without Reduction: A Randomized Controlled Trial
The study aims to assess the outcomes of arthroscopic lysis and lavage procedure with and without single intra-articular injection of hyaluronic acid in managing patients with anterior disc displacement without reduction.
The research question that this study will answer is:
Does arthroscopic lysis and lavage combined with hyaluronic acid provide better outcomes in terms of pain intensity and maximum mouth opening compared to arthroscopic lysis and lavage alone?
- Conditions
- TMJ Disc Disorder, Temporomandibular Joint Disc Displacement, Without Reduction, TMD/Orofacial Pain, Temporomandibular Disorder, TMJ Closed Lock
- Being tested
- Arthroscopic lysis and lavage, arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid
- Keywords
- TMJ arthroscopy, TMJ arthroscopic lysis and lavage, Anterior Disc Displacement without reduction
- 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.
Arthroscopic lysis and lavageProcedure or surgery
Arthroscopic lysis and lavage without intra-articular hyaluronic acid injection
arthroscopic lysis and lavage with intra-articular injection of hyaluronic acidProcedure or surgery
Arthroscopic lysis and lavage followed by intra-articular injection of hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic lysis and lavage | Active comparator | Not described Receives: Procedure: Arthroscopic lysis and lavage |
| Arthroscopic lysis and lavage with single intra-articular hyaluronic acid injection | Experimental | Not described Receives: Procedure: arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS) ranging from 0 to 10 , where 10 indicates no pain and 10 indicates worst pain
Measured: baseline enrollment, preoperatively on day of surgery, Week 1, Month 1, Month 3, and Month 6 after intervention
Secondary outcomes (1)
Maximum mouth opening
Maximum mouth opening will be measured as the distance between the upper and lower incisors using a digital caliper and recorded in millimeters
Measured: baseline enrollment, preoperatively on day of the surgery, week 1, Month 1, Month 3, and Month 6 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TMJ Disc DisorderStudies 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
- Model description
- Participants are randomized into two separate groups and each participant receives only one intervention throughout the study: 1. Arthroscopic lysis and lavage alone 2. Arthroscopic lysis and lavage + hyaluronic acid injection
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eshraq Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614932
- Sponsor's protocol ID
- Arthroscopic Lysis and Lavage
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez 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 38601255Castano-Joaqui OG, Cano-Sanchez J, Campo-Trapero J, Munoz-Guerra MF. TMJ arthroscopy with hyaluronic acid: A 12-month randomized clinical trial. Oral Dis. 2021 Mar;27(2):301-311. doi: 10.1111/odi.13524. Epub 2020 Jul 25.
PubMed 32609918Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Arthroscopic Lysis and Lavage With And Without Intra-Articular Injection of Hyaluronic Acid in the Management of Patients With Disc Displacement Without Reduction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07614932
- Acronym / sponsor ID
- Arthroscopic Lysis and Lavage
- Conditions
- TMJ Disc Disorder, Temporomandibular Joint Disc Displacement, Without Reduction, TMD/Orofacial Pain, Temporomandibular Disorder, TMJ Closed Lock
- Keywords
- TMJ arthroscopy, TMJ arthroscopic lysis and lavage, Anterior Disc Displacement without reduction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 May 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.
The study aims to assess the outcomes of arthroscopic lysis and lavage procedure with and without single intra-articular injection of hyaluronic acid in managing patients with anterior disc displacement without reduction.
The research question that this study will answer is:
Does arthroscopic lysis and lavage combined with hyaluronic acid provide better outcomes in terms of pain intensity and maximum mouth opening compared to arthroscopic lysis and lavage alone?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized into two separate groups and each participant receives only one intervention throughout the study: 1. Arthroscopic lysis and lavage alone 2. Arthroscopic lysis and lavage + hyaluronic acid injection
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic lysis and lavage | Active comparator | Procedure: Arthroscopic lysis and lavage |
| Arthroscopic lysis and lavage with single intra-articular hyaluronic acid injection | Experimental | Procedure: arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults above 18 years old.
- Diagnosis of Disc Displacement Without Reduction (DDWOR) with limited mouth : eitherunilateral or bilateral based on the DC/TMD and confirmed with MRI
- History of unsuccessful conservative treatment such as physical therapy, occlusal splints,or medications (e.g., NSAIDs, muscle relaxants) for at least 3 months.
- Patients must sign the informed consent, understand the study procedures and potential risks, accept to volunteer in the study and be available to attend the follow-up visits.
Key exclusion criteria (6 listed)
- Degenerative Temporomandibular Joint Disorders (e.g., osteoarthritis, rheumatoid arthritis).
- History of prior TMJ surgery (e.g., joint replacement, previous arthroscopy).
- Severe Systemic Conditions (e.g., cardiovascular disease, autoimmune disorders, uncontrolled diabetes).
- Active joint infection, acute inflammation, or presence of any condition that may increase the risk of complications from arthroscopic surgery or injections (e.g., local infection, uncontrolled bleeding disorders).
- Pregnancy or Breastfeeding.
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 lysis and lavageArthroscopic lysis and lavage without intra-articular hyaluronic acid injection | Procedure or surgery | Arthroscopic lysis and lavage |
| arthroscopic lysis and lavage with intra-articular injection of hyaluronic acidArthroscopic lysis and lavage followed by intra-articular injection of hyaluronic acid | Procedure or surgery | Arthroscopic lysis and lavage with single intra-articular hyaluronic acid injection |
Primary outcome
Pain intensity
Time frame: baseline enrollment, preoperatively on day of surgery, Week 1, Month 1, Month 3, and Month 6 after intervention
Pain intensity will be assessed using the Visual Analog Scale (VAS) ranging from 0 to 10 , where 10 indicates no pain and 10 indicates worst pain
1 secondary outcome
Maximum mouth opening
Time frame: baseline enrollment, preoperatively on day of the surgery, week 1, Month 1, Month 3, and Month 6 after 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 29 May 2026.
- Background: 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.
- Background: PubMed 32609918Castano-Joaqui OG, Cano-Sanchez J, Campo-Trapero J, Munoz-Guerra MF. TMJ arthroscopy with hyaluronic acid: A 12-month randomized clinical trial. Oral Dis. 2021 Mar;27(2):301-311. doi: 10.1111/odi.13524. Epub 2020 Jul 25.
- Background: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- 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.
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 lysis and lavage and arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid in people with TMJ Disc Disorder and Temporomandibular Joint Disc Displacement, Without Reduction, 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 4 inclusion and 6 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 29 May 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 Eshraq Ahmed ElMetwally (+201287472001, eshraq.elmetwally@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 (time frame: baseline enrollment, preoperatively on day of surgery, Week 1, Month 1, Month 3, and Month 6 after intervention). 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 NCT07614932, which also lists 3 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 29 May 2026.