TMJ DisorderNCT05882604
MESNA Injection for TMJ Internal Derangement
A study testing Mesna Injection and Arthrocentesis with ringer solution in people with TMJ Disorder, run by Tanta University at 1 site in Egypt.
Trial summary
The pathogenesis of temporomandibular disorders focusing on the biochemistry of the synovial fluid in various stages of temporomandibular joint disease. The role of inflammation has been investigated and proposed as an underlying mechanism of pain and dysfunction of temporomandibular joint. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TMJ Disorder
- What is being tested?
- Mesna Injection and Arthrocentesis with ringer solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 10 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with TMJ internal derangement with reduction
Who cannot join
- inflammatory or connective tissue disease
- autoimmune disease history
- neurologic problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection
The pathogenesis of temporomandibular disorders focusing on the biochemistry of the synovial fluid in various stages of temporomandibular joint disease. The role of inflammation has been investigated and proposed as an underlying mechanism of pain and dysfunction of temporomandibular joint. MESNA (sodium 2-mercaptoethanesulfonate) was approved several years ago and marketed in several formulations as a mucolytic agent in the respiratory field, since it breaks the disulfide bonds between polypeptide chains of mucus. The tissue distribution of MESNA is negligible, and the elimination of the substance is rapidly and completely achieved by kidney
Read the detailed description
Clarification (July 2025): Recruitment was completed in March 2023 following clinical scheduling and preliminary departmental clearance, while formal written ethical approval was finalized in early April 2023. All patients were followed up for one year, and the study was completed by March 2024.
- Conditions
- TMJ Disorder
- Being tested
- Mesna Injection, Arthrocentesis with ringer solution
- 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.
Mesna InjectionDrug
1 ml of MESNA will be injected using 20-guage needle in he upper compartment of TMJ in patient with internal derrangement.
Arthrocentesis with ringer solutionDrug
Two 20-gauge needles will be placed into upper joint space as entry and exit points for washing.The arthrocentesis will be performed with 100 ml of lactated Ringer's solution to eliminate the inflammatory mediators present in the synovial fluid
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular injection with MESNA solution | Experimental | 1 ml of MESNA will be injected intra-articular Receives: Drug: Mesna Injection |
| Arthrocentesis with ringer solution | Active comparator | ringer solution will be used for arthrocentesis Receives: Drug: Arthrocentesis with ringer solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal interincisal opening (MIO)
a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative
Measured: 6 months
Secondary outcomes (2)
Joint pain
pain will be assessed on a visual analogue scale (VAS) with a score between 0 and 10, 0 means no pain and 10 means severe pain
Measured: 6 months
clicking sound
yes or no questionnaire,yes mean clicking is present and no means clicking disappeared
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 posted31 May 2023
- Study start1 Mar 2023
- Primary completion10 Mar 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ DisorderStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdellatif Abdelfatah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882604
- Sponsor's protocol ID
- #R-OS-4-23-3
- Status last verified
- Jul 2025
- First submitted
- 22 May 2023
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Temporomandibular Joint Internal Derangement Using MESNA Injection
- ClinicalTrials.gov ID
- NCT05882604
- Acronym / sponsor ID
- #R-OS-4-23-3
- Conditions
- TMJ Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 31 May 2023 (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 pathogenesis of temporomandibular disorders focusing on the biochemistry of the synovial fluid in various stages of temporomandibular joint disease. The role of inflammation has been investigated and proposed as an underlying mechanism of pain and dysfunction of temporomandibular joint. MESNA (sodium 2-mercaptoethanesulfonate) was approved several years ago and marketed in several formulations as a mucolytic agent in the respiratory field, since it breaks the disulfide bonds between polypeptide chains of mucus. The tissue distribution of MESNA is negligible, and the elimination of the substance is rapidly and completely achieved by kidney
Detailed description
Clarification (July 2025): Recruitment was completed in March 2023 following clinical scheduling and preliminary departmental clearance, while formal written ethical approval was finalized in early April 2023. All patients were followed up for one year, and the study was completed by March 2024.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular injection with MESNA solution | Experimental | Drug: Mesna Injection1 ml of MESNA will be injected intra-articular |
| Arthrocentesis with ringer solution | Active comparator | Drug: Arthrocentesis with ringer solutionringer solution will be used for arthrocentesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with TMJ internal derangement with reduction
Key exclusion criteria (3 listed)
- inflammatory or connective tissue disease
- autoimmune disease history
- neurologic problems
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 |
|---|---|---|
| Mesna Injection1 ml of MESNA will be injected using 20-guage needle in he upper compartment of TMJ in patient with internal derrangement. | Drug | Intra-articular injection with MESNA solution |
| Arthrocentesis with ringer solutionTwo 20-gauge needles will be placed into upper joint space as entry and exit points for washing.The arthrocentesis will be performed with 100 ml of lactated Ringer's solution to eliminate the inflammatory mediators present in the synovial fluid | Drug | Arthrocentesis with ringer solution |
Primary outcome
maximal interincisal opening (MIO)
Time frame: 6 months
a digital caliper will be employed to measure the maximum interincisal opening pre and postoperative
2 secondary outcomes
Joint pain
Time frame: 6 months
clicking sound
Time frame: 6 months
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 24 Jul 2025.
- 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. 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 Mesna Injection and Arthrocentesis with ringer solution in people with TMJ Disorder, run by Tanta 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 1 inclusion and 3 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 24 Jul 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.
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?
maximal interincisal opening (MIO) (time frame: 6 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 24 Jul 2025.