NCT05815771

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.4 years

First QC Date

March 13, 2023

Last Update Submit

April 4, 2023

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (1)

  • Mandibular mouth opening

    Measuring Maximum interincisal opening measured by plastic scale ruler in millimeter

    6 Months

Secondary Outcomes (3)

  • Post-operative pain

    six months follow-up

  • Joint sound

    six months follow-up

  • Lateral and protrusive movements

    six months follow-up

Study Arms (3)

Micro fragmented adipose tissue

ACTIVE COMPARATOR

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 cellsProcedure: Bone Marrow stem cells aspirate

Bone marrow stem cells aspiration

ACTIVE COMPARATOR

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

Procedure: Micro fragmented adipose tissue mixed with bone marrow stem cellsProcedure: Bone Marrow stem cells aspirate

hyaluronic acid gel injection

PLACEBO COMPARATOR

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 cellsProcedure: Bone Marrow stem cells aspirate

Interventions

Micro fragmented adipose tissue mixed with bone marrow stem cellsPROCEDURE

mixture of stem cells

Bone marrow stem cells aspirationMicro fragmented adipose tissuehyaluronic acid gel injection
Bone Marrow stem cells aspiratePROCEDURE

stem cells

Bone marrow stem cells aspirationMicro fragmented adipose tissuehyaluronic acid gel injection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo university

Cairo, Egypt

Location

Mohamed Talaat Abbas Hassan

Cairo, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 13, 2023

First Posted

April 18, 2023

Study Start

July 1, 2023

Primary Completion

December 1, 2024

Study Completion

July 1, 2025

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

EG(2)