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Not yet recruitingNCT05815771Updated Apr 18, 2023

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

An interventional study of Micro fragmented adipose tissue mixed with bone marrow stem cells and Bone Marrow stem cells aspirate in Temporomandibular Joint Disorders, sponsored by Mohamed Talaat Abbas Hassan. Not yet recruiting at 2 sites in Egypt. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Mohamed Talaat Abbas Hassan · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Temporomandibular Joint Disorders

609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.

This study's planned enrollment of 24 is below the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.

Browse Temporomandibular Joint Disorders studies →

Lead sponsor

This is the only study on the registry with Mohamed Talaat Abbas Hassan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with TMDs not previously surgically treated.
  • Patients with TMJ osteoarthritis assessed by clinical examination and magnetic resonance imaging.

Exclusion criteria

Exclusion Criteria:

  • Patients refuse to be enrolled in this study.
  • Patients with uncontrolled systemic disease.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
24 participants (estimated)

Study arms

  • 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 · Procedure: Bone Marrow stem cells aspirate

  • 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 · Procedure: Bone Marrow stem cells aspirate

  • 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 · Procedure: Bone Marrow stem cells aspirate

Interventions

  • ProcedureMicro fragmented adipose tissue mixed with bone marrow stem cells

    mixture of stem cells

  • ProcedureBone Marrow stem cells aspirate

    stem cells

06

What researchers measure

Primary outcomes

  1. Mandibular mouth opening

    Measuring Maximum interincisal opening measured by plastic scale ruler in millimeter

    Time frame: 6 Months

Secondary outcomes

  1. 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

    Time frame: six months follow-up

  2. Joint sound

    Clicking by clinical examination indicate ( present or absent ) of clicking

    Time frame: six months follow-up

  3. Lateral and protrusive movements

    Measuring lateral and protrusive movements by using range of motion scale in millimeter

    Time frame: six months follow-up

07

Study locations

2 sites
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05815771
Lead sponsor
Mohamed Talaat Abbas Hassan
Responsible party
Mohamed Talaat Abbas Hassan (Principle investigator, Cairo University) — Sponsor-investigator
First posted
Apr 18, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Dec 1, 2024 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Apr 18, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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