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

April 4, 2023 updated by: Mohamed Talaat Abbas Hassan

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Micro fragmented adipose tissue
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
mixture of stem cells
Procedure: Bone Marrow stem cells aspirate
stem cells
Active Comparator: Bone marrow stem cells aspiration
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
mixture of stem cells
Procedure: Bone Marrow stem cells aspirate
stem cells
Placebo Comparator: hyaluronic acid gel injection
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
mixture of stem cells
Procedure: Bone Marrow stem cells aspirate
stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mandibular mouth opening
Time Frame: 6 Months
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
Time Frame: 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
six months follow-up
Joint sound
Time Frame: six months follow-up
Clicking by clinical examination indicate ( present or absent ) of clicking
six months follow-up
Lateral and protrusive movements
Time Frame: six months follow-up
Measuring lateral and protrusive movements by using range of motion scale in millimeter
six months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mohamed Talaat Abbas Hassan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stem cells injection of TMJ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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