Temporomandibular Joint DisordersNCT05815771
Clinical and Magnetic Resonance Imaging Evaluation of Micro Fragmented Adipose Tissue Injection Combined With Bone Marrow Stem Cells on Healing of Temporomandibular Joint Internal Disc Derangement Without Reduction
A study testing Micro fragmented adipose tissue mixed with bone marrow stem cells and Bone Marrow stem cells aspirate in people with Temporomandibular Joint Disorders, run by Mohamed Talaat Abbas Hassan at 2 sites in Egypt.
Trial summary
Arthrocentesis of TMJ then injection of micro fragmented adipose tissue mixed with bone marrow aspirate on healing of TMJ internal disc derangement without reduction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- Micro fragmented adipose tissue mixed with bone marrow stem cells and Bone Marrow stem cells aspirate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2023to 1 Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with TMDs not previously surgically treated.
- Patients with TMJ osteoarthritis assessed by clinical examination and magnetic resonance imaging.
Who cannot join
- Patients refuse to be enrolled in this study.
- Patients with uncontrolled systemic disease.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo university
Cairo
Mohamed Hassan, 01005661353, mohamedabbas@dentistry.cu.edu.eg
Mohamed Talaat Abbas Hassan
Cairo
Mohamed Hassan, 01005661353, mohamedabbas@dentistry.cu.edu.eg
Mohamed Hassan
About this study
Official title: Clinical and Magnetic Resonance Imaging Evaluation of Micro Fragmented Adipose Tissue Injection Combined With Bone Marrow Stem Cells on Healing of Temporomandibular Joint Internal Disc Derangement Without Reduction (Randomized Control Pilot Clinical Trial)
Arthrocentesis of TMJ then injection of micro fragmented adipose tissue mixed with bone marrow aspirate on healing of TMJ internal disc derangement without reduction.
Read the detailed description
Arthrocentesis of TMJ then injection of intra and periarticular of 2 mm of micro fragmented adipose tissue mixed with Bone marrow aspirate extracted from 20 mm of bone marrow using gradient separation method in one group and use of Bone marrow aspirate injection only in another group and injection of intra and periarticular of 2 mm hyaluronic acid gel in control group on healing of TMJ internal disc derangement without reduction.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- Micro fragmented adipose tissue mixed with bone marrow stem cells, Bone Marrow stem cells aspirate
- 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.
Micro fragmented adipose tissue mixed with bone marrow stem cellsProcedure or surgery
mixture of stem cells
Bone Marrow stem cells aspirateProcedure or surgery
stem cells
| Study group | Role | What they receive |
|---|---|---|
| Micro fragmented adipose tissue | Active comparator | Micro fragmented adipose tissue mixed with Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction Receives: Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells; Procedure: Bone Marrow stem cells aspirate |
| Bone marrow stem cells aspiration | Active comparator | Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction Receives: Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells; Procedure: Bone Marrow stem cells aspirate |
| hyaluronic acid gel injection | Placebo comparator | Intra and periarticular injection of 2 mm of hyaluronic acid gel on healing of TMJ internal disc derangement without reduction Receives: Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells; Procedure: Bone Marrow stem cells aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mandibular mouth opening
Measuring Maximum interincisal opening measured by plastic scale ruler in millimeter
Measured: 6 Months
Secondary outcomes (3)
Post-operative pain
measuring pain by using visual analogue scale from (0 to 10) score where zero indicate no pain and 10 indicate worst pain
Measured: six months follow-up
Joint sound
Clicking by clinical examination indicate ( present or absent ) of clicking
Measured: six months follow-up
Lateral and protrusive movements
Measuring lateral and protrusive movements by using range of motion scale in millimeter
Measured: six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jul 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 DisordersStudies 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Talaat Abbas Hassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Talaat Abbas Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815771
- Sponsor's protocol ID
- Stem cells injection of TMJ
- Status last verified
- Apr 2023
- First submitted
- 13 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Magnetic Resonance Imaging Evaluation of Micro Fragmented Adipose Tissue Injection Combined With Bone Marrow Stem Cells on Healing of Temporomandibular Joint Internal Disc Derangement Without Reduction (Randomized Control Pilot Clinical Trial)
- ClinicalTrials.gov ID
- NCT05815771
- Acronym / sponsor ID
- Stem cells injection of TMJ
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mohamed Talaat Abbas HassanUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 18 Apr 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.
Arthrocentesis of TMJ then injection of micro fragmented adipose tissue mixed with bone marrow aspirate on healing of TMJ internal disc derangement without reduction.
Detailed description
Arthrocentesis of TMJ then injection of intra and periarticular of 2 mm of micro fragmented adipose tissue mixed with Bone marrow aspirate extracted from 20 mm of bone marrow using gradient separation method in one group and use of Bone marrow aspirate injection only in another group and injection of intra and periarticular of 2 mm hyaluronic acid gel in control group on healing of TMJ internal disc derangement without reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Micro fragmented adipose tissue | Active comparator | Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells, Procedure: Bone Marrow stem cells aspirateMicro fragmented adipose tissue mixed with Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction |
| Bone marrow stem cells aspiration | Active comparator | Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells, Procedure: Bone Marrow stem cells aspirateBone marrow stem cells injection on healing of TMJ internal disc derangement without reduction |
| hyaluronic acid gel injection | Placebo comparator | Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells, Procedure: Bone Marrow stem cells aspirateIntra and periarticular injection of 2 mm of hyaluronic acid gel on healing of TMJ internal disc derangement without reduction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with TMDs not previously surgically treated.
- Patients with TMJ osteoarthritis assessed by clinical examination and magnetic resonance imaging.
Key exclusion criteria (2 listed)
- Patients refuse to be enrolled in this study.
- Patients with uncontrolled systemic disease.
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 |
|---|---|---|
| Micro fragmented adipose tissue mixed with bone marrow stem cellsmixture of stem cells | Procedure or surgery | Bone marrow stem cells aspiration, Micro fragmented adipose tissue, hyaluronic acid gel injection |
| Bone Marrow stem cells aspiratestem cells | Procedure or surgery | Bone marrow stem cells aspiration, Micro fragmented adipose tissue, hyaluronic acid gel injection |
Primary outcome
Mandibular mouth opening
Time frame: 6 Months
Measuring Maximum interincisal opening measured by plastic scale ruler in millimeter
3 secondary outcomes
Post-operative pain
Time frame: six months follow-up
Joint sound
Time frame: six months follow-up
Lateral and protrusive movements
Time frame: six months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro fragmented adipose tissue mixed with bone marrow stem cells and Bone Marrow stem cells aspirate in people with Temporomandibular Joint Disorders, run by Mohamed Talaat Abbas Hassan at 2 sites 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 2 inclusion and 2 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mandibular mouth opening (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 18 Apr 2023.