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

Not Applicable

Not yet recruiting

• Conditions: Temporomandibular Joint Disorders
• Interventions: Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cells; Procedure: Bone Marrow stem cells aspirate

• Registration Number: NCT05815771
• Lead Sponsor: Mohamed Talaat Abbas Hassan

Brief 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.

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 Timeline

• Study First Submitted: 2023-03-13
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Study Start: 2023-07-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bone marrow stem cells aspiration	Micro fragmented adipose tissue mixed with bone marrow stem cells	Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction
Bone marrow stem cells aspiration	Bone Marrow stem cells aspirate	Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction
hyaluronic acid gel injection	Micro fragmented adipose tissue mixed with bone marrow stem cells	Intra and periarticular injection of 2 mm of hyaluronic acid gel on healing of TMJ internal disc derangement without reduction
Micro fragmented adipose tissue	Micro fragmented adipose tissue mixed with bone marrow stem cells	Micro fragmented adipose tissue mixed with Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction
Micro fragmented adipose tissue	Bone Marrow stem cells aspirate	Micro fragmented adipose tissue mixed with Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction
hyaluronic acid gel injection	Bone Marrow stem cells aspirate	Intra and periarticular injection of 2 mm of hyaluronic acid gel on healing of TMJ internal disc derangement without reduction

Primary Outcome Measures

Name	Time	Method
Mandibular mouth opening	6 Months	Measuring Maximum interincisal opening measured by plastic scale ruler in millimeter

Secondary Outcome Measures

Name	Time	Method
Joint sound	six months follow-up	Clicking by clinical examination indicate ( present or absent ) of clicking
Post-operative pain	six months follow-up	measuring pain by using visual analogue scale from (0 to 10) score where zero indicate no pain and 10 indicate worst pain
Lateral and protrusive movements	six months follow-up	Measuring lateral and protrusive movements by using range of motion scale in millimeter

Trial Locations

Locations (2)

Mohamed Talaat Abbas Hassan; 🇪🇬 Cairo, Egypt

Cairo university; 🇪🇬 Cairo, Egypt