Temporomandibular Joint OsteoarthritisNCT06425263
Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis
A study testing adipose tissue fragmented in people with Temporomandibular Joint Osteoarthritis, run by Cairo University.
Trial summary
Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis. Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Temporomandibular Joint Osteoarthritis
- What is being tested?
- adipose tissue fragmented
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2025
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- * TMJ osteoarthritis assessed by clinical examination and MRI imaging
- Presence of TMJ-related symptoms including at least limited mouth opening and joint pain
- Previously failed conservative treatment
- Age superior to 14 years
- No previous TMJ surgical procedures
- Acquisition of informed consent;
- Complete availability of the data acquired preoperatively and during each follow-up
- Patients free from any systemic disease that may affect the procedure.
Who cannot join
- * Previously diagnosed hematological and neurological conditions;
- Previous malignant head and neck neoplasms;
- Contraindication to fat harvesting.
- Uncooperative patients.
About this study
Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis.
Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.
Read the detailed description
Rationale for conducting the research:
The rationale of 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 intraarticular injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function
compared with arthrocentesis and intraarticular injection of hyaluronic acid (HA) 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 standard arthrocentesis with HA injection.
- Conditions
- Temporomandibular Joint Osteoarthritis
- Being tested
- adipose tissue fragmented
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose tissue fragmentedBiological
harvested from the case form buccal pad of fat
| Study group | Role | What they receive |
|---|---|---|
| injection with adipose tissue | Experimental | After standard arthrocentesis of the temporomandibular joint
* 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 . Receives: Biological: adipose tissue fragmented |
| injection with hyaluronic acids | Active comparator | Arthrocentesis of the superior joint compartment was performed in all patients under local anesthesia using the technique described by Nitzan et al.
Another 19-gauge needle was inserted into the distended compartment in the area of the articular eminence, and the superior joint space was irrigated with 200 mL saline solution, allowing a free flow through the first needle.
On termination of procedure, 2 mL commercially available hyaluronic injected into the superior compartment. Receives: Biological: adipose tissue fragmented |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
by Vas measurement scale OF PAIN
Measured: 3 months
Secondary outcomes (1)
mouth opening
degree of opening on each visit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison between injection of hyaluronic acids and adipose tissue in temporomandibular joint
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mutaz Alkhair Hamad Elsayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425263
- Sponsor's protocol ID
- OMFS 335
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dose Lipogems injection affect TMJ derangement more than hyaluronic acid in treatment of the temporomandibular joint osteoarthritis and internal derangement? Statement of the problem: Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis. Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis
- ClinicalTrials.gov ID
- NCT06425263
- Acronym / sponsor ID
- OMFS 335
- Conditions
- Temporomandibular Joint Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 22 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.
Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis.
Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.
Detailed description
Rationale for conducting the research:
The rationale of 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 intraarticular injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function
compared with arthrocentesis and intraarticular injection of hyaluronic acid (HA) 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 standard arthrocentesis with HA injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- comparison between injection of hyaluronic acids and adipose tissue in temporomandibular joint
| Arm | Type | Receives |
|---|---|---|
| injection with adipose tissue | Experimental | Biological: adipose tissue fragmentedAfter standard arthrocentesis of the temporomandibular joint * 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 . |
| injection with hyaluronic acids | Active comparator | Biological: adipose tissue fragmentedArthrocentesis of the superior joint compartment was performed in all patients under local anesthesia using the technique described by Nitzan et al. Another 19-gauge needle was inserted into the distended compartment in the area of the articular eminence, and the superior joint space was irrigated with 200 mL saline solution, allowing a free flow through the first needle. On termination of procedure, 2 mL commercially available hyaluronic injected into the superior compartment. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- * TMJ osteoarthritis assessed by clinical examination and MRI imaging
Key exclusion criteria (4 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 |
|---|---|---|
| adipose tissue fragmentedharvested from the case form buccal pad of fat | Biological | injection with adipose tissue, injection with hyaluronic acids |
Primary outcome
VAS
Time frame: 3 months
by Vas measurement scale OF PAIN
1 secondary outcome
mouth opening
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: Yes. Dose Lipogems injection affect TMJ derangement more than hyaluronic acid in treatment of the temporomandibular joint osteoarthritis and internal derangement? Statement of the problem: Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis. Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing adipose tissue fragmented in people with Temporomandibular Joint Osteoarthritis, 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 8 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: status not confirmed, as of the sponsor's last update on 22 May 2024. 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.
Are results available for this study?
Results are not available in the source record.
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?
VAS (time frame: 3 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 22 May 2024.