TMJ Disc Displacement With ReductionNCT07683650
Hyaluronic Acid and I-PRF Mixture for TMJ Disc Displacement Management
A study testing 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution, Arthrocentesis followed by hyaluronic acid injection and Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture in people with TMJ Disc Displacement With Reduction, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the efficacy of hyaluronic acid and I-PRF mixture for intra-articular injection following arthrocentesis in the management of TMJ reducible disc displacement. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- TMJ Disc Displacement With Reduction
- What is being tested?
- 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution, Arthrocentesis followed by hyaluronic acid injection and Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jan 2026to Feb 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 - 45 years.
- Patients with disc displacement with reduction in any of the TMJs.
- arthralgia.
- Limited unassisted mouth opening.
- Co-operative patients.
Who cannot join
- Patients with previous history of TMJ minimally invasive interventions.
- Patients with autoimmune or connective tissue diseases affecting the joints.
- Patients with neurological disorders.
- Patients with a history of condylar fractures or ankylosis.
- Patients with psychological problems.
- Patients receiving non-steroidal anti-inflammatory drugs within 48 hours preoperatively, or systemic use of corticosteroids within 2 weeks.
- Patients on anticoagulants, suffering from platelet function disorders or fibrinogen deficiency.
- Patients with moderate to severe myogenic pain.
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, 1 recruiting
- Recruiting
Faculty of Dentistry Mansoura University
Al Mansurah
Faculty of Dentistry Mansoura University, 0020502267151, dentfac@mans.edu.eg
About this study
Official title: Evaluation of Hyaluronic Acid and I-PRF Mixture for Intra-articular Injection Following Arthrocentesis in The Management of TMJ Reducible Disc Displacement: A Four Arm Comparative Trial
The aim of this study is to evaluate the efficacy of hyaluronic acid and I-PRF mixture for intra-articular injection following arthrocentesis in the management of TMJ reducible disc displacement.
Read the detailed description
The purpose of this four-arm comparative clinical trial is to evaluate the efficacy of a combined intra-articular injection of Hyaluronic Acid (HA) and Injectable Platelet-Rich Fibrin (i-PRF) following arthrocentesi in patients suffering from temporomandibular joint (TMJ) reducible disc displacement.
All eligible participants will undergo standard TMJ arthrocentesis using Ringer's lactate solution to flush out inflammatory mediators and disrupt intra-articular adhesions.
Patients will be randomly assigned to one of four treatment protocols to compare therapeutic outcomes:
Group I: Arthrocentesis alone (Control). Group II: Arthrocentesis followed by intra-articular injection of Hyaluronic Acid only.
Group III: Arthrocentesis followed by intra-articular injection of a Hyaluronic Acid and Betamethasone mixture.
Group IV: Arthrocentesis followed by intra-articular injection of a Hyaluronic Acid and I-PRF mixture (Experimental).
Clinical outcomes include changes in maximum pain-free mouth opening, lateral/protrusive jaw movements, subjective pain intensity scores and presence or absence of clicking Clinical outcomes will be monitored and evaluated over a 6-month post-operative follow-up period to assess which intervention provides the most effective relief and functional restoration.
- Conditions
- TMJ Disc Displacement With Reduction
- Being tested
- 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution, Arthrocentesis followed by hyaluronic acid injection, Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture, Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture
- Keywords
- TMJ, Disc Displacement With Reduction, Arthrocentesis, Hyaluronic Acid, I-PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18 joints that receive arthrocentesis using 100 ml of ringer lactate solutionProcedure or surgery
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution
Arthrocentesis followed by hyaluronic acid injectionProcedure or surgery
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of 1 ml of hyaluronic acid
Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixtureProcedure or surgery
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and betamethasone mixture
Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixtureProcedure or surgery
18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and I-PRF mixture
| Study group | Role | What they receive |
|---|---|---|
| Group I: Arthrocentesis only | Active comparator | Not described Receives: Procedure: 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution |
| Group II: Arthrocentesis followed by hyaluronic acid injection | Active comparator | Not described Receives: Procedure: Arthrocentesis followed by hyaluronic acid injection |
| Group III: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture | Active comparator | Not described Receives: Procedure: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture |
| Group IV: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture | Active comparator | Not described Receives: Procedure: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
Pain intensity will be evaluated subjectively using Numeric Rating Scale from zero to 10 zero indicates no pain at all 10 indicates the worst pain ever
Measured: preoperative, one week, one month, 3 months and 6 months
Maximum interincisal opening, lateral and protrusive movements
- Maximum interincisal opening: the distance in millimeters between the incisal edges of the central incisors in vertical direction at maximum pain free mouth opening, measured using a caliper.
- Range of lateral and protrusive movements: the distance in millimeters between the upper and lower midlines in horizontal direction on lateral and protrusive movements, measured using a caliper.
Measured: preoperative, one week, one month, 3 months and 6 months
Secondary outcomes (1)
Clicking
clicking will be evaluated as either present or absent throughout the follow up intervals
Measured: preoperative, one week, one month, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start6 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMJ Disc Displacement With ReductionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nada Hamed, Principal investigator, Faculty of Dentistry Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683650
- Sponsor's protocol ID
- MS.25.12.93
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 14 Jul 2026
- 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 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hyaluronic Acid and I-PRF Mixture for Intra-articular Injection Following Arthrocentesis in The Management of TMJ Reducible Disc Displacement: A Four Arm Comparative Trial
- ClinicalTrials.gov ID
- NCT07683650
- Acronym / sponsor ID
- MS.25.12.93
- Conditions
- TMJ Disc Displacement With Reduction
- Keywords
- TMJ, Disc Displacement With Reduction, Arthrocentesis, Hyaluronic Acid, I-PRF
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 Jul 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 aim of this study is to evaluate the efficacy of hyaluronic acid and I-PRF mixture for intra-articular injection following arthrocentesis in the management of TMJ reducible disc displacement.
Detailed description
The purpose of this four-arm comparative clinical trial is to evaluate the efficacy of a combined intra-articular injection of Hyaluronic Acid (HA) and Injectable Platelet-Rich Fibrin (i-PRF) following arthrocentesi in patients suffering from temporomandibular joint (TMJ) reducible disc displacement.
All eligible participants will undergo standard TMJ arthrocentesis using Ringer's lactate solution to flush out inflammatory mediators and disrupt intra-articular adhesions.
Patients will be randomly assigned to one of four treatment protocols to compare therapeutic outcomes:
Group I: Arthrocentesis alone (Control). Group II: Arthrocentesis followed by intra-articular injection of Hyaluronic Acid only.
Group III: Arthrocentesis followed by intra-articular injection of a Hyaluronic Acid and Betamethasone mixture.
Group IV: Arthrocentesis followed by intra-articular injection of a Hyaluronic Acid and I-PRF mixture (Experimental).
Clinical outcomes include changes in maximum pain-free mouth opening, lateral/protrusive jaw movements, subjective pain intensity scores and presence or absence of clicking Clinical outcomes will be monitored and evaluated over a 6-month post-operative follow-up period to assess which intervention provides the most effective relief and functional restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I: Arthrocentesis only | Active comparator | Procedure: 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution |
| Group II: Arthrocentesis followed by hyaluronic acid injection | Active comparator | Procedure: Arthrocentesis followed by hyaluronic acid injection |
| Group III: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture | Active comparator | Procedure: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture |
| Group IV: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture | Active comparator | Procedure: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18 - 45 years.
- Patients with disc displacement with reduction in any of the TMJs.
- arthralgia.
- Limited unassisted mouth opening.
- Co-operative patients.
Key exclusion criteria (8 listed)
- Patients with previous history of TMJ minimally invasive interventions.
- Patients with autoimmune or connective tissue diseases affecting the joints.
- Patients with neurological disorders.
- Patients with a history of condylar fractures or ankylosis.
- Patients with psychological 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 |
|---|---|---|
| 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution18 joints that receive arthrocentesis using 100 ml of ringer lactate solution | Procedure or surgery | Group I: Arthrocentesis only |
| Arthrocentesis followed by hyaluronic acid injection18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of 1 ml of hyaluronic acid | Procedure or surgery | Group II: Arthrocentesis followed by hyaluronic acid injection |
| Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and betamethasone mixture | Procedure or surgery | Group III: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture |
| Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture18 joints that receive arthrocentesis using 100 ml of ringer lactate solution followed by intra-articular injection of hyaluronic acid and I-PRF mixture | Procedure or surgery | Group IV: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture |
Primary outcome
Intensity of pain
Time frame: preoperative, one week, one month, 3 months and 6 months
Pain intensity will be evaluated subjectively using Numeric Rating Scale from zero to 10 zero indicates no pain at all 10 indicates the worst pain ever
Maximum interincisal opening, lateral and protrusive movements
Time frame: preoperative, one week, one month, 3 months and 6 months
1. Maximum interincisal opening: the distance in millimeters between the incisal edges of the central incisors in vertical direction at maximum pain free mouth opening, measured using a caliper. 2. Range of lateral and protrusive movements: the distance in millimeters between the upper and lower midlines in horizontal direction on lateral and protrusive movements, measured using a caliper.
1 secondary outcome
Clicking
Time frame: preoperative, one week, one month, 3 months and 6 months
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 14 Jul 2026.
- Individual participant dataSharing planned: No
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Assessment of Injectable PRF Versus Dextrose Injection in Temporomandibular Joint in Anterior Disc Displacement With Reduction
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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.
Nada Hamed principal investigator
Faculty of Dentistry Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution, Arthrocentesis followed by hyaluronic acid injection and Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture in people with TMJ Disc Displacement With Reduction, 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 8 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: looking for participants now, as of the sponsor's last update on 14 Jul 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 Nada Hamed (00201119659235, hamednada99@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (time frame: preoperative, one week, one month, 3 months and 6 months). The study lists 2 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 14 Jul 2026.