Temporomandibular Joint Internal DerangementNCT07743684
Clinical Effectiveness of Combined Arthrocentesis With Intra-articular Injection of Meloxicam in Treatment of Temporomandibular Joint Internal Derangement
A study testing Arthrocentesis with ringer lactate solution and meloxicam injection and Arthrocentesis with ringer lactate solution in people with Temporomandibular Joint Internal Derangement, run by Hussein Mohammed Ridha at 1 site in Iraq.
Trial summary
This randomized controlled clinical study is designed to evaluate the clinical effectiveness of combining temporomandibular joint (TMJ) arthrocentesis with a single intra-articular injection of meloxicam in patients suffering from TMJ internal derangement. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Temporomandibular Joint Internal Derangement
- What is being tested?
- Arthrocentesis with ringer lactate solution and meloxicam injection and Arthrocentesis with ringer lactate solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2026to Oct 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients >= 18 years diagnosed clinically with unilateral TMJ internal derangement with or without reduction, based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
- Failure of conservative therapy (splint therapy, physiotherapy) for at least 1 month.
- Willing and able to provide written informed consent.
Who cannot join
- Patients with bilateral TMJ internal derangement.
- History of TMJ surgery or major trauma on the affected side.
- Presence of rheumatic disease.
- Severe degenerative joint disease.
- Active infection around the TMJ.
- Known bleeding disorders or patients on anticoagulant therapy.
Show all 9Show fewer
- Pregnancy or lactation.
- Allergy to Meloxicam or its components.
- Received intra-articular injections (corticosteroids, hyaluronic acid) in the TMJ within at least 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled clinical study is designed to evaluate the clinical effectiveness of combining temporomandibular joint (TMJ) arthrocentesis with a single intra-articular injection of meloxicam in patients suffering from TMJ internal derangement.
Temporomandibular disorders (TMD) are common conditions causing pain, restricted jaw movement, and joint sounds, which can significantly impair patients' quality of life. While conventional treatments include conservative approaches and arthrocentesis alone, finding optimal therapeutic protocols remains crucial for refractory cases.
Read more
A total of 50 adult patients diagnosed with unilateral TMJ internal derangement (with or without reduction) who have failed at least one month of conservative therapy will be enrolled and randomly allocated into two equal groups:
Study Group: Will undergo joint arthrocentesis followed by a single intra-articular injection of meloxicam (15 mg / 1.5 mL).
Control Group: Will undergo joint arthrocentesis alone using Ringer's lactate solution.
Patients will be evaluated across a 12-week postoperative period (at 2, 4, 8, and 12 weeks) to assess primary and secondary outcomes, including pain intensity (measured via a Numerical Rating Scale), maximum mouth opening (inter-incisal distance in millimeters), joint sounds (clicking, popping, or crepitus), and overall patient satisfaction. The findings aim to establish whether adding an intra-articular non-steroidal anti-inflammatory drug (NSAID) enhances the therapeutic benefits of standard TMJ arthrocentesis.
- Being tested
- Arthrocentesis with ringer lactate solution and meloxicam injection, Arthrocentesis with ringer lactate solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrocentesis with ringer lactate solution and meloxicam injectionDrug
Intra-articular injection of 1ml of meloxical after TMJ arthrocentesis
Arthrocentesis with ringer lactate solutionDrug
Arthrocentesis of the TMJ with ringer lactate only
| Study group | Role | What they receive |
|---|---|---|
| Meloxicam | Active comparator | Arthrocentesis with ringer lactate solution and meloxicam injection Receives: Drug: Arthrocentesis with ringer lactate solution and meloxicam injection |
| Control | Sham comparator | Arthrocentesis with ringer lactate solution only Receives: Drug: Arthrocentesis with ringer lactate solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Mouth Opening (MMO)
Inter-incisal distance measured in millimeters using a digital caliper or standard ruler.
Measured: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)
Pain intensity
Measured using a 0-10 pain numerical rating scale , where 0 equals no pain and 10 equals the worst pain possible.
The score indicates the degree of pain experienced by the patient by the patient at the baseline evaluation. Minimum score is 0, and the maximum score is 10.
During the follow-up visits , decreasing pain score indicates better outcome, while increasing pain score indicates worse outcome.
Measured: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)
Presence or Absence of Joint Sounds
Clinical examination evaluating the TMJ for joint sounds such as clicking, popping noise, or crepitus.
Measured: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)
Secondary outcomes (1)
Patient Satisfaction
Patient Satisfaction evaluated using the 5-point Likert-like scale ranging from the minimum score: 1 (very dissatisfied) to the maximum score: 5 (very satisfied), where higher scores indicate a better outcome.
Measured: Recorded at the final 12-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Internal DerangementStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hussein Mohammed Ridha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hussein Mohammed Ridha, Yarmook Hospital
- Investigators
- Salwan Yousif Bede, B.D.S, F.I.B.M.S, Study director, Iraqi board for medical specialities
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743684
- Sponsor's protocol ID
- 21925
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Combined Arthrocentesis With Intra-articular Injection of Meloxicam in Treatment of Temporomandibular Joint Internal Derangement
- ClinicalTrials.gov ID
- NCT07743684
- Acronym / sponsor ID
- 21925
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hussein Mohammed RidhaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 4 Aug 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.
This randomized controlled clinical study is designed to evaluate the clinical effectiveness of combining temporomandibular joint (TMJ) arthrocentesis with a single intra-articular injection of meloxicam in patients suffering from TMJ internal derangement.
Temporomandibular disorders (TMD) are common conditions causing pain, restricted jaw movement, and joint sounds, which can significantly impair patients' quality of life. While conventional treatments include conservative approaches and arthrocentesis alone, finding optimal therapeutic protocols remains crucial for refractory cases.
A total of 50 adult patients diagnosed with unilateral TMJ internal derangement (with or without reduction) who have failed at least one month of conservative therapy will be enrolled and randomly allocated into two equal groups:
Study Group: Will undergo joint arthrocentesis followed by a single intra-articular injection of meloxicam (15 mg / 1.5 mL).
Control Group: Will undergo joint arthrocentesis alone using Ringer's lactate solution.
Patients will be evaluated across a 12-week postoperative period (at 2, 4, 8, and 12 weeks) to assess primary and secondary outcomes, including pain intensity (measured via a Numerical Rating Scale), maximum mouth opening (inter-incisal distance in millimeters), joint sounds (clicking, popping, or crepitus), and overall patient satisfaction. The findings aim to establish whether adding an intra-articular non-steroidal anti-inflammatory drug (NSAID) enhances the therapeutic benefits of standard TMJ arthrocentesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meloxicam | Active comparator | Drug: Arthrocentesis with ringer lactate solution and meloxicam injectionArthrocentesis with ringer lactate solution and meloxicam injection |
| Control | Sham comparator | Drug: Arthrocentesis with ringer lactate solutionArthrocentesis with ringer lactate solution only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients >= 18 years diagnosed clinically with unilateral TMJ internal derangement with or without reduction, based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
- Failure of conservative therapy (splint therapy, physiotherapy) for at least 1 month.
- Willing and able to provide written informed consent.
Key exclusion criteria (9 listed)
- Patients with bilateral TMJ internal derangement.
- History of TMJ surgery or major trauma on the affected side.
- Presence of rheumatic disease.
- Severe degenerative joint disease.
- Active infection around the TMJ.
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 |
|---|---|---|
| Arthrocentesis with ringer lactate solution and meloxicam injectionIntra-articular injection of 1ml of meloxical after TMJ arthrocentesis | Drug | Meloxicam |
| Arthrocentesis with ringer lactate solutionArthrocentesis of the TMJ with ringer lactate only | Drug | Control |
Primary outcome
Maximum Mouth Opening (MMO)
Time frame: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)
Inter-incisal distance measured in millimeters using a digital caliper or standard ruler.
Pain intensity
Time frame: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)
Measured using a 0-10 pain numerical rating scale , where 0 equals no pain and 10 equals the worst pain possible. The score indicates the degree of pain experienced by the patient by the patient at the baseline evaluation. Minimum score is 0, and the maximum score is 10. During the follow-up visits , decreasing pain score indicates better outcome, while increasing pain score indicates worse outcome.
Presence or Absence of Joint Sounds
Time frame: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)
Clinical examination evaluating the TMJ for joint sounds such as clicking, popping noise, or crepitus.
1 secondary outcome
Patient Satisfaction
Time frame: Recorded at the final 12-week follow-up.
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 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Temporomandibular Joint Internal Derangement
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Temporomandibular Disc Displacement
Temporomandibular Disorders (TMD), Internal Derangement of the Tempromandibular Joint
Active, not recruitingPhase 2
Evaluation of Intravenous Sodium Valproate on Interleukin-6 Levels in Patients With TMJ Disc Displacement
Temporomandibular Joint Internal Derangement (ADWR)
Not yet recruiting
A Prospective Randomized Clinical Trial Comparing a Fast-Fix-Enhanced Arthroscopic System Versus Conventional Arthroscopic Suturing for Temporomandibular Disc Repositioning in Internal Derangement: Functional, Clinical, and Surgical Outcomes
Temporomandibular Joint Internal Derangement
Active, not recruiting
Computer Guided Single Needle Arthrocentesis
Temporomandibular Disorder (TMD), Internal Derangement
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.
Salwan Yousif Bede, B.D.S, F.I.B.M.S study director
Iraqi board for medical specialities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrocentesis with ringer lactate solution and meloxicam injection and Arthrocentesis with ringer lactate solution in people with Temporomandibular Joint Internal Derangement, run by Hussein Mohammed Ridha at 1 site in Iraq.
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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 3 Sep 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 Iraq. 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. Some participants in this study may receive a placebo. 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?
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 Mouth Opening (MMO) (time frame: Up to 12 weeks postoperatively (evaluated at baseline, 2, 4, 8, and 12 weeks)). 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?
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 3 Sep 2026.