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NCT05815771 Clinical Trial

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

Temporomandibular Joint Disorders Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05815771
Other study ID # Stem cells injection of TMJ
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date July 1, 2025

Study information
Verified date April 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 24
Est. completion date July 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

  • Joint Diseases
  • Temporomandibular Joint Disorders
  • Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• Micro fragmented adipose tissue mixed with bone marrow stem cells
mixture of stem cells
• Bone Marrow stem cells aspirate
stem cells

Locations
Country Name City State
Egypt Cairo university Cairo
Egypt Mohamed Talaat Abbas Hassan Cairo

Sponsors (1)
Lead Sponsor Collaborator
Mohamed Talaat Abbas Hassan

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mandibular mouth opening Measuring Maximum interincisal opening measured by plastic scale ruler in millimeter 6 Months
Secondary 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
Secondary Joint sound Clicking by clinical examination indicate ( present or absent ) of clicking six months follow-up
Secondary Lateral and protrusive movements Measuring lateral and protrusive movements by using range of motion scale in millimeter six months follow-up
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