TMJ Disc DisorderPhase 2/3NCT07107399
Therapeutic Effect of Microfragmented Adipose Tissue (Lipogems) Injection on Maximum Interincisal Opening Versus Injectable Platelet-rich Plasma (PRP) for the Treatment of Anterior Disc Displacement With Reduction : A Randomized Clinical Trial
A Phase 2/3 study testing microfragmented adipose tissue and platelet-rich plasma in people with TMJ Disc Disorder, run by Cairo University.
Trial summary
this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect. The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with injection of autologous micro fragmented adipose tissue leads to better clinical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- microfragmented adipose tissue and platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2025to 1 Dec 2025
- Phase
- Phase 2/3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients should have one or more signs and symptoms of these
- Disc displacement assessed by clinical examination and MRI
- Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
- Mouth Opening: Limited range of motion or difficulty with full mouth opening .
- Clicking: Audible clicking.
- Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.
Who cannot join
- Previously diagnosed hematological and neurological conditions;
- Previous malignant head and neck neoplasms;
- Contraindication to fat harvesting.
- Uncooperative patients.
- connective tissue disorders.
- a pacemaker or any other metal prosthesis in the body.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ahmed Hosni ali, bachelor's degree contact
About this study
this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.
The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function compared with arthrocentesis and injection of platelets rich plasma (prp)in patients with TMJ internal derangement and osteoarthritis.
Read more
Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.
Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.
For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of micro fragmented fat tissue can achieve the same improvements of pain and function, compare this technique with prp injection.
Read the detailed description
Anterior disc displacement with reduction (DDwR) of the temporomandibular joint (TMJ) is a prevalent condition characterized by the displacement of the articular disc during jaw movement, often leading to pain, clicking sounds, and restricted mouth opening. Traditional treatments include conservative approaches such as physical therapy, occlusal splints, and pharmacological interventions. However, for patients unresponsive to these methods, intra-articular injections of regenerative therapies like microfragmented adipose tissue (MFAT) and platelet-rich plasma (PRP) have emerged as promising alternatives.
Arthrocentesis first described by Nitzan et al. [1.2] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment.
Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.
In addition to arthrocentesis:
Microfragmented Adipose Tissue (MFAT) Injections MFAT involves the extraction and processing of adipose tissue to create a suspension rich in mesenchymal stem cells, growth factors, and extracellular matrix components. This suspension is then injected into the affected joint to promote tissue repair and reduce inflammation.
A study published in Stem Cells Translational Medicine in 2023 evaluated the efficacy of MFAT injections in patients with knee osteoarthritis. The results demonstrated significant improvements in joint pain and functionality, with median changes in the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscale ranging from 18.1 at week 2 to 27.8 at 1 year. These findings suggest that MFAT may be a viable alternative treatment for patients with joint conditions who fall into the orthopedic treatment gap.
While this study focused on knee osteoarthritis, the regenerative properties of MFAT suggest potential applicability to TMJ disorders. However, further research is needed to confirm its effectiveness in the TMJ context.
Platelet-Rich Plasma (PRP) Injections PRP therapy involves concentrating platelets from the patient's own blood and injecting them into the affected joint to stimulate healing.
A systematic review published in BMC Oral Health in 2024 examined the effectiveness of PRP injections for TMJ disorders. The review concluded that PRP injections, particularly when combined with arthrocentesis, were effective in reducing pain and improving mandibular function in patients with TMJ internal derangement.
Additionally, a study in the Open Journal of Stomatology in 2023 evaluated the effect of platelet-rich growth factors (PRGFs) in the treatment of TMJ disc displacement. The results indicated that PRGFs could be a possible alternative treatment for patients who did not respond to standard treatments, showing early efficacy in reducing pain and improving joint function.
Comparative Efficacy While both MFAT and PRP injections have demonstrated efficacy in treating joint disorders, direct comparative studies in the context of TMJ anterior disc displacement with reduction are limited. The existing literature primarily focuses on individual therapies rather than head-to-head comparisons. Therefore, it is challenging to definitively conclude which treatment offers superior outcomes for TMJ disorders.
- Conditions
- TMJ Disc Disorder
- Being tested
- microfragmented adipose tissue, platelet-rich plasma
- Keywords
- lipogem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microfragmented adipose tissueOther
Receive micro fragmented adipose tissue obtained from the buccal pad of fat after arthrocentessis.
- Direct access to the buccal fat pad, is found at distobuccal depth of the maxillary tuberosity.
- It may be dissected during the resection an upper mucosal incision posterior to the second molar
- After a single scissor stab through the periosteum the (BFP)extrude into the operative site.
- Closure of the flap by suitable suture.
- Collection of lipids then manually manipulated with two syringes connecting together and pushing the lipids against each other to receive the injectable amount of micro fragmented adipose tissue .
- Ready for TMJ injection.
platelet-rich plasmaOther
I - double-puncture arthrocentesis technique was followed, and 300 mL of Ringer's lactate solution was used to irrigate the joint space through the marked points . After arthrocentesis PRP was prepared from 5 mL of autologous venous blood sample taken from the antecubital vein. The collected blood was then transferred to a test tube containing 0.5 mL of sodium citrate (anticoagulant) (0.5 mL) and was centrifuged at a rate of 2100 rpm for 15 min. The plasma from the first harvest was fractionated by centrifugation at 3500 rpm for 10 min to prepare PRP.
| Study group | Role | What they receive |
|---|---|---|
| platelet-rich plasma | Active comparator | Not described Receives: Other: platelet-rich plasma |
| microfragmented adipose tissue | Experimental | Not described Receives: Other: microfragmented adipose tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum interincisal opening
maximum interincisal opening and it is measured by caliper in mm
Measured: 1 week , 3 months
Secondary outcomes (2)
change in pain severity
pain severity will be assessed using vas scale (0-10) where 0 = no pain and 10 = sever pain . participants will report their pain level at each time point
Measured: 1 week , 3 months
presence or absence of joint clicking (binary outcome)
joint clicking will be assessed as a binary outcome (yes/no)based on the clinical examination and patient-reported symptoms
Measured: 1 week , 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start5 Aug 2025 (estimated)
- Primary completion5 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
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 Cairo 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- B) Injectable Lipogems, a form of adipose (fat) tissue-derived regenerative medicine, is an emerging treatment for a variety of musculoskeletal conditions, including TMJ disorders such as anterior disc displacement with reduction. Lipogems involves harvesting and processing a small amount of the patient's own fat tissue, then injecting it into the affected area. Here's why Lipogems is considered an important option in treating TMJ disorders with anterior disc displacement with reduction. Lipogems contains a rich concentration of regenerative cells, such as mesenchymal stem cells (MSCs), along with growth factors, cytokines, and other bioactive molecules. These components play a crucial role in tissue regeneration, healing, and the repair of damaged structures within the TMJ, such as the articular disc, ligaments, and surrounding tissues. These growth factors can support the healing process of the damaged tissues that may be contributing to the disc displacement.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed hosni, Cairo University
- Investigators
- Ahmed Hosni Ahmed Hosni Ali, bachelor's degree, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107399
- Sponsor's protocol ID
- tmj injection
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mittal A, Klarie SJ, Sharma S, Roy B, Paul JI, Sharma S. Efficacy of Intra-articular Platelet-rich Plasma versus Hydrocortisone with Local Anaesthetic Injection in Temporomandibular Joint Disorders - A Prospective Study. Ann Maxillofac Surg. 2024 Jul-Dec;14(2):166-170. doi: 10.4103/ams.ams_237_23. Epub 2024 Sep 11.
PubMed 39957867
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Microfragmented Adipose Tissue (Lipogems) Injection on Maximum Interincisal Opening Versus Injectable Platelet-rich Plasma (PRP) for the Treatment of Anterior Disc Displacement With Reduction : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07107399
- Acronym / sponsor ID
- tmj injection
- Conditions
- TMJ Disc Disorder
- Keywords
- lipogem
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Aug 2025 (estimated)
- Primary completion
- 5 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 6 Aug 2025 (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 procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.
The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function compared with arthrocentesis and injection of platelets rich plasma (prp)in patients with TMJ internal derangement and osteoarthritis.
Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.
Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.
For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of micro fragmented fat tissue can achieve the same improvements of pain and function, compare this technique with prp injection.
Detailed description
Anterior disc displacement with reduction (DDwR) of the temporomandibular joint (TMJ) is a prevalent condition characterized by the displacement of the articular disc during jaw movement, often leading to pain, clicking sounds, and restricted mouth opening. Traditional treatments include conservative approaches such as physical therapy, occlusal splints, and pharmacological interventions. However, for patients unresponsive to these methods, intra-articular injections of regenerative therapies like microfragmented adipose tissue (MFAT) and platelet-rich plasma (PRP) have emerged as promising alternatives.
Arthrocentesis first described by Nitzan et al. [1.2] is the simplest intervention on the TMJ with the aim to decrease joint pain and improve the range of motion in patients not responding to initial conservative treatment.
Arthrocentesis consists of an intraarticular lavage using 2 needles placed in the upper joint space. It is a versatile technique which can be performed under local anesthesia in an outpatient setting as well Arthrocentesis has been demonstrated to be a very effective procedure with a high success rate and a favorable benefit-cost ratio.
In addition to arthrocentesis:
Microfragmented Adipose Tissue (MFAT) Injections MFAT involves the extraction and processing of adipose tissue to create a suspension rich in mesenchymal stem cells, growth factors, and extracellular matrix components. This suspension is then injected into the affected joint to promote tissue repair and reduce inflammation.
A study published in Stem Cells Translational Medicine in 2023 evaluated the efficacy of MFAT injections in patients with knee osteoarthritis. The results demonstrated significant improvements in joint pain and functionality, with median changes in the Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscale ranging from 18.1 at week 2 to 27.8 at 1 year. These findings suggest that MFAT may be a viable alternative treatment for patients with joint conditions who fall into the orthopedic treatment gap.
While this study focused on knee osteoarthritis, the regenerative properties of MFAT suggest potential applicability to TMJ disorders. However, further research is needed to confirm its effectiveness in the TMJ context.
Platelet-Rich Plasma (PRP) Injections PRP therapy involves concentrating platelets from the patient's own blood and injecting them into the affected joint to stimulate healing.
A systematic review published in BMC Oral Health in 2024 examined the effectiveness of PRP injections for TMJ disorders. The review concluded that PRP injections, particularly when combined with arthrocentesis, were effective in reducing pain and improving mandibular function in patients with TMJ internal derangement.
Additionally, a study in the Open Journal of Stomatology in 2023 evaluated the effect of platelet-rich growth factors (PRGFs) in the treatment of TMJ disc displacement. The results indicated that PRGFs could be a possible alternative treatment for patients who did not respond to standard treatments, showing early efficacy in reducing pain and improving joint function.
Comparative Efficacy While both MFAT and PRP injections have demonstrated efficacy in treating joint disorders, direct comparative studies in the context of TMJ anterior disc displacement with reduction are limited. The existing literature primarily focuses on individual therapies rather than head-to-head comparisons. Therefore, it is challenging to definitively conclude which treatment offers superior outcomes for TMJ disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- B) Injectable Lipogems, a form of adipose (fat) tissue-derived regenerative medicine, is an emerging treatment for a variety of musculoskeletal conditions, including TMJ disorders such as anterior disc displacement with reduction. Lipogems involves harvesting and processing a small amount of the patient's own fat tissue, then injecting it into the affected area. Here's why Lipogems is considered an important option in treating TMJ disorders with anterior disc displacement with reduction. Lipogems contains a rich concentration of regenerative cells, such as mesenchymal stem cells (MSCs), along with growth factors, cytokines, and other bioactive molecules. These components play a crucial role in tissue regeneration, healing, and the repair of damaged structures within the TMJ, such as the articular disc, ligaments, and surrounding tissues. These growth factors can support the healing process of the damaged tissues that may be contributing to the disc displacement.
| Arm | Type | Receives |
|---|---|---|
| platelet-rich plasma | Active comparator | Other: platelet-rich plasma |
| microfragmented adipose tissue | Experimental | Other: microfragmented adipose tissue |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients should have one or more signs and symptoms of these
Key exclusion criteria (6 listed)
- Previously diagnosed hematological and neurological conditions;
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 |
|---|---|---|
| microfragmented adipose tissueReceive micro fragmented adipose tissue obtained from the buccal pad of fat after arthrocentessis. * Direct access to the buccal fat pad, is found at distobuccal depth of the maxillary tuberosity. * It may be dissected during the resection an upper mucosal incision posterior to the second molar * After a single scissor stab through the periosteum the (BFP)extrude into the operative site. * Closure of the flap by suitable suture. * Collection of lipids then manually manipulated with two syringes connecting together and pushing the lipids against each other to receive the injectable amount of micro fragmented adipose tissue . * Ready for TMJ injection. | Other | microfragmented adipose tissue |
| platelet-rich plasmaI - double-puncture arthrocentesis technique was followed, and 300 mL of Ringer's lactate solution was used to irrigate the joint space through the marked points . After arthrocentesis PRP was prepared from 5 mL of autologous venous blood sample taken from the antecubital vein. The collected blood was then transferred to a test tube containing 0.5 mL of sodium citrate (anticoagulant) (0.5 mL) and was centrifuged at a rate of 2100 rpm for 15 min. The plasma from the first harvest was fractionated by centrifugation at 3500 rpm for 10 min to prepare PRP. | Other | platelet-rich plasma |
Primary outcome
maximum interincisal opening
Time frame: 1 week , 3 months
maximum interincisal opening and it is measured by caliper in mm
2 secondary outcomes
change in pain severity
Time frame: 1 week , 3 months
presence or absence of joint clicking (binary outcome)
Time frame: 1 week , 3 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 6 Aug 2025.
- Results publication: PubMed 39957867Mittal A, Klarie SJ, Sharma S, Roy B, Paul JI, Sharma S. Efficacy of Intra-articular Platelet-rich Plasma versus Hydrocortisone with Local Anaesthetic Injection in Temporomandibular Joint Disorders - A Prospective Study. Ann Maxillofac Surg. 2024 Jul-Dec;14(2):166-170. doi: 10.4103/ams.ams_237_23. Epub 2024 Sep 11.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Hosni ali, bachelor's degree contact
Ahmed Hosni Ahmed Hosni Ali, bachelor's degree study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing microfragmented adipose tissue and platelet-rich plasma in people with TMJ Disc Disorder, run by Cairo University.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmed Hosni ali, bachelor's degree (01552252413 ext. 01559006602, ahmed.hosni@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum interincisal opening (time frame: 1 week , 3 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 NCT07107399, 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 6 Aug 2025.