Temporomandibular Joint Disc Displacement, With ReductionPhase 1/2NCT06403046
Does Successive Intra-articular Injections of Tenoxicam or Meloxicam Affect Treatment of TMJ Displacement
A Phase 1/2 study testing intraarticular injection in people with Temporomandibular Joint Disc Displacement, With Reduction, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The temporomandibular joint's (TMJ) articular disc, situated between the mandibular condyle's convexity and the articular tubercle's slope, is the most intricate synovial articulation in the human body. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disc Displacement, With Reduction
- What is being tested?
- intraarticular injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 7 Sep 2025
- Phase
- Phase 1/2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of both sexes with an age range of 18-45 years.
- Those patients with the radiographic interpretation of unilateral or bilateral (TMJ) anterior disc displacement with reduction with the clinical signs of pain, limitation of mouth opening, and TMJ clicking; Wilkes classification type II.
Who cannot join
- Clinical or radiographic signs of disc displacement without reduction, osteoarthritis, or articular bony changes.
- Previous (TMJ) surgery, arthrocentesis, or occlusal splints.
- Any systemic disease affecting the temporomandibular joint's anatomy, mechanical function, or outcome of the proposed treatment.
- Those Patients with a history of allergic reactions to any components of the injectable solutions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Successive Intra-articular Injections of Tenoxicam or Meloxicam Affect Treatment Outcomes of Temporomandibular Joint Anterior Disc Displacement With Reduction? (A Randomized Controlled Trial)
The temporomandibular joint's (TMJ) articular disc, situated between the mandibular condyle's convexity and the articular tubercle's slope, is the most intricate synovial articulation in the human body. While the usual discal position as defined by magnetic resonance imaging (MRI) places the posterior discal band at the 12 o'clock position atop the mandibular condyle's maximum convexity, this discal disposition is altered in over 30% of the population without any accompanying physical symptoms. This denotes that rather than correcting the anatomical disc position, the treatment for discal displacement would primarily focus on symptom relief.
Read the detailed description
Up until 1975, the only treatment options for (TMJ) internal derangement were surgical procedures that involved either repositioning the articular disc or removing it. Arthroscopic lavage was first described by Ohnishi as a way to dissolve adhesions and remove the inflammatory mediators, which reduced the pain, increased the mouth opening, and increased the harmony between the mandibular condyle and the articular disc, even though their native anatomical relation was not restored. Nitzan et al. in 1991 described arthrocentesis as a conservative method for (TMJ) lavage that discarded the arthroscopic morbidity and the need for costly tools and primarily aimed to utilize the hydraulic pressure of the lavage solution to wash out the inflammatory mediators, and release the articular disc adhesions.
The direct injection of a therapeutic agent into a joint cavity is known as intra-articular injection. Which usually aims to relieve arthralgia, suppress inflammation, and enhance joint function.
Various therapeutic agents are being deposited intra-articularly, including corticosteroids, hyaluronic acid, platelet-rich plasma and fibrin, opioids, corticosteroids, anxiolytics, muscle relaxants, antidepressants, anticonvulsants, and nonsteroidal anti-inflammatory drugs (NSAIDs).
(NSAIDs) the direct inhibition of the cyclooxygenase (COX) conversion of arachidonic acid to prostaglandins has been used to treat inflammatory articular diseases.
Oxicam-derived Tenoxicam and Meloxicam are inexpensive and readily available (NSAIDs); frequently injected intraarticularly following knee arthroscopy and (TMJ) arthrocentesis by virtue of their sustained drug delivery and long-lasting inflammatory effect.
Tenoxicam is a nonselective (NSAID) that inhibits both COX-1 and COX-2. On the other hand, Meloxicam is a selective COX-2 inhibitor.
The study aims to design a randomized controlled trial that compares the effect of intra-articular injection of the non-selective (NSAID) Tenoxicam versus the selective COX-2 inhibitor Meloxicam after arthrocentesis on alleviating the clinical signs and symptoms of (TMJ) disc displacement with reduction.
- Being tested
- intraarticular injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraarticular injectionDrug
Also called arthrocentesis
all patients will be subjected to routine (TMJ) arthrocentesis followed by Tenoxicam injection into the superior joint space in the (Tx group) and Meloxicam injection among the patients of (Mx group).
| Study group | Role | What they receive |
|---|---|---|
| The Study group | Experimental | The study represents a randomized clinical trial that compares the short- and long-term effects of three repeated intraarticular injections of Tenoxicam post-arthrocentesis immediately, after one month, and two months after, with a one-month interval between each injection, for the alleviation of constitutional symptoms in patients with TMJ anterior disc displacement with reduction. Receives: Drug: intraarticular injection |
| The Control group | Experimental | The study represents a randomized clinical trial that compares the short- and long-term effects of three repeated intraarticular injections of Meloxicam post-arthrocentesis immediately, after one month, and two months after, with a one-month interval between each injection, for the alleviation of constitutional symptoms in patients with TMJ anterior disc displacement with reduction. Receives: Drug: intraarticular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clicking
Absence or presence of clicking
Measured: 9 months
Visual analogue scale
Scale from 1 to 10 which the 10 is the worst pain
Measured: 9 months
Maximal interincisal opening
Increase in interincisal opening
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Jun 2024
- Primary completion7 May 2025
- Study completion7 Sep 2025
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 Temporomandibular Joint Disc Displacement, With ReductionStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- two groups each groups consists of 15 participants \& the total number of participants is 30 as the patients are divided into (Tx group) and (Mx group) after labeling them in sequential numbers
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Nagi Alghandour, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403046
- Sponsor's protocol ID
- 9
- Status last verified
- Sep 2025
- First submitted
- 3 May 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibaly A, Alghandour AN, Abdelmoiz M. Do successive intra-articular injections of tenoxicam or meloxicam affect the treatment outcomes of temporomandibular joint anterior disc displacement with reduction? (a randomized controlled trial). Oral Maxillofac Surg. 2026 Apr 10;30(1):68. doi: 10.1007/s10006-026-01552-6.
PubMed 41957190
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Successive Intra-articular Injections of Tenoxicam or Meloxicam Affect Treatment Outcomes of Temporomandibular Joint Anterior Disc Displacement With Reduction? (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT06403046
- Acronym / sponsor ID
- 9
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 Sep 2025 (actual)
- First posted
- 7 May 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.
The temporomandibular joint's (TMJ) articular disc, situated between the mandibular condyle's convexity and the articular tubercle's slope, is the most intricate synovial articulation in the human body. While the usual discal position as defined by magnetic resonance imaging (MRI) places the posterior discal band at the 12 o'clock position atop the mandibular condyle's maximum convexity, this discal disposition is altered in over 30% of the population without any accompanying physical symptoms. This denotes that rather than correcting the anatomical disc position, the treatment for discal displacement would primarily focus on symptom relief.
Detailed description
Up until 1975, the only treatment options for (TMJ) internal derangement were surgical procedures that involved either repositioning the articular disc or removing it. Arthroscopic lavage was first described by Ohnishi as a way to dissolve adhesions and remove the inflammatory mediators, which reduced the pain, increased the mouth opening, and increased the harmony between the mandibular condyle and the articular disc, even though their native anatomical relation was not restored. Nitzan et al. in 1991 described arthrocentesis as a conservative method for (TMJ) lavage that discarded the arthroscopic morbidity and the need for costly tools and primarily aimed to utilize the hydraulic pressure of the lavage solution to wash out the inflammatory mediators, and release the articular disc adhesions.
The direct injection of a therapeutic agent into a joint cavity is known as intra-articular injection. Which usually aims to relieve arthralgia, suppress inflammation, and enhance joint function.
Various therapeutic agents are being deposited intra-articularly, including corticosteroids, hyaluronic acid, platelet-rich plasma and fibrin, opioids, corticosteroids, anxiolytics, muscle relaxants, antidepressants, anticonvulsants, and nonsteroidal anti-inflammatory drugs (NSAIDs).
(NSAIDs) the direct inhibition of the cyclooxygenase (COX) conversion of arachidonic acid to prostaglandins has been used to treat inflammatory articular diseases.
Oxicam-derived Tenoxicam and Meloxicam are inexpensive and readily available (NSAIDs); frequently injected intraarticularly following knee arthroscopy and (TMJ) arthrocentesis by virtue of their sustained drug delivery and long-lasting inflammatory effect.
Tenoxicam is a nonselective (NSAID) that inhibits both COX-1 and COX-2. On the other hand, Meloxicam is a selective COX-2 inhibitor.
The study aims to design a randomized controlled trial that compares the effect of intra-articular injection of the non-selective (NSAID) Tenoxicam versus the selective COX-2 inhibitor Meloxicam after arthrocentesis on alleviating the clinical signs and symptoms of (TMJ) disc displacement with reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- two groups each groups consists of 15 participants \& the total number of participants is 30 as the patients are divided into (Tx group) and (Mx group) after labeling them in sequential numbers
| Arm | Type | Receives |
|---|---|---|
| The Study group | Experimental | Drug: intraarticular injectionThe study represents a randomized clinical trial that compares the short- and long-term effects of three repeated intraarticular injections of Tenoxicam post-arthrocentesis immediately, after one month, and two months after, with a one-month interval between each injection, for the alleviation of constitutional symptoms in patients with TMJ anterior disc displacement with reduction. |
| The Control group | Experimental | Drug: intraarticular injectionThe study represents a randomized clinical trial that compares the short- and long-term effects of three repeated intraarticular injections of Meloxicam post-arthrocentesis immediately, after one month, and two months after, with a one-month interval between each injection, for the alleviation of constitutional symptoms in patients with TMJ anterior disc displacement with reduction. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients of both sexes with an age range of 18-45 years.
- Those patients with the radiographic interpretation of unilateral or bilateral (TMJ) anterior disc displacement with reduction with the clinical signs of pain, limitation of mouth opening, and TMJ clicking; Wilkes classification type II.
Key exclusion criteria (4 listed)
- Clinical or radiographic signs of disc displacement without reduction, osteoarthritis, or articular bony changes.
- Previous (TMJ) surgery, arthrocentesis, or occlusal splints.
- Any systemic disease affecting the temporomandibular joint's anatomy, mechanical function, or outcome of the proposed treatment.
- Those Patients with a history of allergic reactions to any components of the injectable solutions.
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 |
|---|---|---|
| intraarticular injectionAlso: arthrocentesisall patients will be subjected to routine (TMJ) arthrocentesis followed by Tenoxicam injection into the superior joint space in the (Tx group) and Meloxicam injection among the patients of (Mx group). | Drug | The Control group, The Study group |
Primary outcome
Clicking
Time frame: 9 months
Absence or presence of clicking
Visual analogue scale
Time frame: 9 months
Scale from 1 to 10 which the 10 is the worst pain
Maximal interincisal opening
Time frame: 9 months
Increase in interincisal opening
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 16 Sep 2025.
- Derived from this study: PubMed 41957190Gibaly A, Alghandour AN, Abdelmoiz M. Do successive intra-articular injections of tenoxicam or meloxicam affect the treatment outcomes of temporomandibular joint anterior disc displacement with reduction? (a randomized controlled trial). Oral Maxillofac Surg. 2026 Apr 10;30(1):68. doi: 10.1007/s10006-026-01552-6.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Joint Disc Displacement, With Reduction
Recruiting
Calcium Gluconate Activated in Anterior Disc Displacement With Reduction of the Temporomandibular Joint
Temporomandibular Joint Disorders
Not yet recruiting
Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction
Temporo-mandibular Dysfunction, Disc Displacement
Active, not recruitingPhase 2
Assessment of Injectable PRF Versus Dextrose Injection in Temporomandibular Joint in Anterior Disc Displacement With Reduction
TMD
Recruiting
Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement
Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint
RecruitingObservational study
Long-term Follow up of TMJ Surgery and Evaluation of the 6-month Control as a Prognostic Marker.
Temporomandibular Disorders (TMD), Temporomandibular Joint Disc Displacement, With Reduction
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 Phase 1/2 study testing intraarticular injection in people with Temporomandibular Joint Disc Displacement, With Reduction, run by Beni-Suef 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 4 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 16 Sep 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clicking (time frame: 9 months). 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?
On the ClinicalTrials.gov record for NCT06403046, 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 16 Sep 2025.