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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Temporomandibular Joint Disorders

Intervention / Treatment
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* Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells
* Procedure: Bone Marrow stem cells aspirate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with TMDs not previously surgically treated. Patients with TMJ osteoarthritis assessed by clinical examination and magnetic resonance imaging. Exclusion Criteria: Patients refuse to be enrolled in this study. Patients with uncontrolled systemic disease.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micro fragmented adipose tissue<br>Micro fragmented adipose tissue mixed with Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction | Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells<br>* mixture of stem cells<br>Procedure: Bone Marrow stem cells aspirate<br>* stem cells<br>|
| Active Comparator: Bone marrow stem cells aspiration<br>Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction | Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells<br>* mixture of stem cells<br>Procedure: Bone Marrow stem cells aspirate<br>* stem cells<br>|
| Placebo Comparator: hyaluronic acid gel injection<br>Intra and periarticular injection of 2 mm of hyaluronic acid gel on healing of TMJ internal disc derangement without reduction | Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells<br>* mixture of stem cells<br>Procedure: Bone Marrow stem cells aspirate<br>* stem cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mandibular mouth opening | Measuring Maximum interincisal opening measured by plastic scale ruler in millimeter | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | six months follow-up | 
| Joint sound | Clicking by clinical examination indicate ( present or absent ) of clicking | six months follow-up | 
| Lateral and protrusive movements | Measuring lateral and protrusive movements by using range of motion scale in millimeter | six months follow-up |