TMJ Disc DisorderNCT06441279
Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials
A study testing intra-articular injection with Platelet lysate (PL). and intra-articular injection with Hyaluronic Acid. in people with TMJ Disc Disorder, run by Mansoura University at 1 site in Egypt.
Trial summary
comparing the clinical efficacy of intra-articular injection of platelet lysate (PL), versus Hyaluronic Acid after arthrocentesis in the management of patients with anterior disc displacement with reduction. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- intra-articular injection with Platelet lysate (PL). and intra-articular injection with 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
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Oct 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients that will be diagnosed with anterior disc displacement with reduction (ADDWR) both clinically and through magnetic resonance imaging scan (MRI).
- Patients who will not respond to a previous conservative therapy.
- Patients with pain in temporomandibular joints.
- Patients with normal or limitation in mouth opening.
- Patients with clicking sound.
Who cannot join
- Patients with previous invasive TMJ surgical procedures.
- Patients with inflammatory or connective tissue diseases.
- Patients with neurologic disorders.
- Patients with history of bony or fibrous adhesion.
- Patients having gross mechanical restrictions and condylar fractures.
- Patients with psychological problems.
- Patients receiving anti-coagulation treatment, non-steroidal anti-inflammatory drugs within 48 hours pre-operatively, corticosteroid injection at the treatment site within one month or systemic use of corticosteroids within 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyaluronic Acid Versus Platelet Lysate in The Treatment of Temporomandibular Joint Anterior Disc Displacement With Reduction: A Randomized Clinical Trial
comparing the clinical efficacy of intra-articular injection of platelet lysate (PL), versus Hyaluronic Acid after arthrocentesis in the management of patients with anterior disc displacement with reduction.
- Conditions
- TMJ Disc Disorder
- Being tested
- intra-articular injection with Platelet lysate (PL)., intra-articular injection with Hyaluronic Acid.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-articular injection with Platelet lysate (PL).Procedure or surgery
2 ml of Platelet lysate will be deposited into the superior joint space (SJS) in the affected joint at the entry point slowly
intra-articular injection with Hyaluronic Acid.Procedure or surgery
2 ml of Hyaluronic Acid will be deposited into the superior joint space (SJS) in the affected joint at the entry point slowly.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | 30 patients that will have intra-articular injection of 2 ml of Platelet lysate (PL). Receives: Procedure: intra-articular injection with Platelet lysate (PL). |
| group 2 | Experimental | 30 patients that will have intra-articular injection of Hyaluronic Acid. Receives: Procedure: intra-articular injection with Hyaluronic Acid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inter-incisal opening
Maximum inter-incisal opening will be measured by Vernier caliper and this will be recorded by photographs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Apr 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Mansoura 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441279
- Sponsor's protocol ID
- A0103024OS
- Status last verified
- Dec 2024
- First submitted
- 29 May 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elsheikh HA, Abdel-Rahman FH, Khaled N, Abdelsameaa SE. Platelet lysate versus hyaluronic acid after arthrocentesis in the treatment of temporomandibular joint anterior disc displacement with reduction: a randomized clinical trial. Odontology. 2026 Apr 30. doi: 10.1007/s10266-026-01397-1. Online ahead of print.
PubMed 42062696
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyaluronic Acid Versus Platelet Lysate in The Treatment of Temporomandibular Joint Anterior Disc Displacement With Reduction: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06441279
- Acronym / sponsor ID
- A0103024OS
- Conditions
- TMJ Disc Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 4 Jun 2024 (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.
comparing the clinical efficacy of intra-articular injection of platelet lysate (PL), versus Hyaluronic Acid after arthrocentesis in the management of patients with anterior disc displacement with reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Procedure: intra-articular injection with Platelet lysate (PL).30 patients that will have intra-articular injection of 2 ml of Platelet lysate (PL). |
| group 2 | Experimental | Procedure: intra-articular injection with Hyaluronic Acid.30 patients that will have intra-articular injection of Hyaluronic Acid. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients that will be diagnosed with anterior disc displacement with reduction (ADDWR) both clinically and through magnetic resonance imaging scan (MRI).
- Patients who will not respond to a previous conservative therapy.
- Patients with pain in temporomandibular joints.
- Patients with normal or limitation in mouth opening.
- Patients with clicking sound.
Key exclusion criteria (7 listed)
- Patients with previous invasive TMJ surgical procedures.
- Patients with inflammatory or connective tissue diseases.
- Patients with neurologic disorders.
- Patients with history of bony or fibrous adhesion.
- Patients having gross mechanical restrictions and condylar fractures.
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 |
|---|---|---|
| intra-articular injection with Platelet lysate (PL).2 ml of Platelet lysate will be deposited into the superior joint space (SJS) in the affected joint at the entry point slowly | Procedure or surgery | group 1 |
| intra-articular injection with Hyaluronic Acid.2 ml of Hyaluronic Acid will be deposited into the superior joint space (SJS) in the affected joint at the entry point slowly. | Procedure or surgery | group 2 |
Primary outcome
Maximum inter-incisal opening
Time frame: 6 months
Maximum inter-incisal opening will be measured by Vernier caliper and this will be recorded by photographs.
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 4 Dec 2024.
- Derived from this study: PubMed 42062696Elsheikh HA, Abdel-Rahman FH, Khaled N, Abdelsameaa SE. Platelet lysate versus hyaluronic acid after arthrocentesis in the treatment of temporomandibular joint anterior disc displacement with reduction: a randomized clinical trial. Odontology. 2026 Apr 30. doi: 10.1007/s10266-026-01397-1. Online ahead of print.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra-articular injection with Platelet lysate (PL). and intra-articular injection with Hyaluronic Acid. in people with TMJ Disc Disorder, run by Mansoura 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 5 inclusion and 7 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 4 Dec 2024. 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?
Maximum inter-incisal opening (time frame: 6 months). 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 NCT06441279, which also lists 1 linked publication.
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 4 Dec 2024.