Back to resultsClinical 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
Primary Purpose
Temporomandibular Joint Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Micro fragmented adipose tissue mixed with bone marrow stem cells
Bone Marrow stem cells aspirate
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Disorders
Eligibility Criteria
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.
Sites / Locations
- Cairo university
- Mohamed Talaat Abbas Hassan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Micro fragmented adipose tissue
Bone marrow stem cells aspiration
hyaluronic acid gel injection
Arm Description
Micro fragmented adipose tissue mixed with Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction
Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction
Intra and periarticular injection of 2 mm of hyaluronic acid gel on healing of TMJ internal disc derangement without reduction
Outcomes
Primary Outcome Measures
Mandibular mouth opening
Measuring Maximum interincisal opening measured by plastic scale ruler in millimeter
Secondary Outcome Measures
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
Joint sound
Clicking by clinical examination indicate ( present or absent ) of clicking
Lateral and protrusive movements
Measuring lateral and protrusive movements by using range of motion scale in millimeter
Full Information
NCT ID
NCT05815771
First Posted
March 13, 2023
Last Updated
April 4, 2023
Sponsor
Mohamed Talaat Abbas Hassan
1. Study Identification
Unique Protocol Identification Number
NCT05815771
Brief 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
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Talaat Abbas Hassan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Micro fragmented adipose tissue
Arm Type
Active Comparator
Arm Description
Micro fragmented adipose tissue mixed with Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction
Arm Title
Bone marrow stem cells aspiration
Arm Type
Active Comparator
Arm Description
Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction
Arm Title
hyaluronic acid gel injection
Arm Type
Placebo Comparator
Arm Description
Intra and periarticular injection of 2 mm of hyaluronic acid gel on healing of TMJ internal disc derangement without reduction
Intervention Type
Procedure
Intervention Name(s)
Micro fragmented adipose tissue mixed with bone marrow stem cells
Intervention Description
mixture of stem cells
Intervention Type
Procedure
Intervention Name(s)
Bone Marrow stem cells aspirate
Intervention Description
stem cells
Primary Outcome Measure Information:
Title
Mandibular mouth opening
Description
Measuring Maximum interincisal opening measured by plastic scale ruler in millimeter
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Post-operative pain
Description
measuring pain by using visual analogue scale from (0 to 10) score where zero indicate no pain and 10 indicate worst pain
Time Frame
six months follow-up
Title
Joint sound
Description
Clicking by clinical examination indicate ( present or absent ) of clicking
Time Frame
six months follow-up
Title
Lateral and protrusive movements
Description
Measuring lateral and protrusive movements by using range of motion scale in millimeter
Time Frame
six months follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Hassan
Phone
01005661353
Email
mohamedabbas@dentistry.cu.edu.eg
Facility Name
Mohamed Talaat Abbas Hassan
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Hassan
Phone
01005661353
Email
mohamedabbas@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohamed Hassan
12. IPD Sharing Statement
Learn more about this 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
We'll reach out to this number within 24 hrs