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

NCT ID: NCT05815771

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-07-01

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.

Conditions

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Temporomandibular Joint Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Micro fragmented adipose tissue

Micro fragmented adipose tissue mixed with Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction

Group Type ACTIVE_COMPARATOR

Micro fragmented adipose tissue mixed with bone marrow stem cells

Intervention Type PROCEDURE

mixture of stem cells

Bone Marrow stem cells aspirate

Intervention Type PROCEDURE

stem cells

Bone marrow stem cells aspiration

Bone marrow stem cells injection on healing of TMJ internal disc derangement without reduction

Group Type ACTIVE_COMPARATOR

Micro fragmented adipose tissue mixed with bone marrow stem cells

Intervention Type PROCEDURE

mixture of stem cells

Bone Marrow stem cells aspirate

Intervention Type PROCEDURE

stem cells

hyaluronic acid gel injection

Intra and periarticular injection of 2 mm of hyaluronic acid gel on healing of TMJ internal disc derangement without reduction

Group Type PLACEBO_COMPARATOR

Micro fragmented adipose tissue mixed with bone marrow stem cells

Intervention Type PROCEDURE

mixture of stem cells

Bone Marrow stem cells aspirate

Intervention Type PROCEDURE

stem cells

Interventions

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Micro fragmented adipose tissue mixed with bone marrow stem cells

mixture of stem cells

Intervention Type PROCEDURE

Bone Marrow stem cells aspirate

stem cells

Intervention Type PROCEDURE

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohamed Talaat Abbas Hassan

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Talaat Abbas Hassan

Principle investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Cairo university

Cairo, , Egypt

Site Status

Mohamed Talaat Abbas Hassan

Cairo, , Egypt

Site Status

Countries

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Egypt

Facility Contacts

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Mohamed Hassan

Role: primary

01005661353

Mohamed Hassan

Role: primary

01005661353

Mohamed Hassan

Role: backup

Other Identifiers

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Stem cells injection of TMJ

Identifier Type: -

Identifier Source: org_study_id

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