## Protocol Section
### Identification Module
**NCT ID:** NCT06425263

**Brief Title:** Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis

**Official Title:** Microfragmented Adipose Tissue Injection Compared to Hyaluronic Acid for Treatment of Temporomandibular Joint Osteoarthritis

#### Organization Study ID Info
**ID:** OMFS 335
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Mutaz Alkhair Hamad Elsayed

**Investigator Title:** principle investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis.

Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.

**Detailed Description:** Rationale for conducting the research:

The rationale of this procedure is to remove inflammatory mediators, reduce friction, stimulate the production of new synovial fluid, eliminate suction-cup effect.

The purpose of this study was to evaluate the hypothesis that TMJ arthrocentesis with intraarticular injection of autologous micro fragmented adipose tissue leads to better clinical outcomes in terms of reducing pain and improving function

compared with arthrocentesis and intraarticular injection of hyaluronic acid (HA) in patients with TMJ internal derangement and osteoarthritis.

Preliminary results of this clinical trial show that the injection of micro fragmented adipose tissue can significantly improve outcomes of pain and function compared with the standard treatment and encourage to pursue research on this topic.

Further studies with a longer follow-up time are needed to evaluate the clinical stability of the achieved improvement in pain and function.

For this reason, this protocol has been designed with the aim to investigate whether injection in the TMJ of micro fragmented fat tissue can achieve the same improvements of pain and function, compare this technique with standard arthrocentesis with HA injection.

### Conditions Module

**Conditions:**

- Temporomandibular Joint Osteoarthritis

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** comparison between injection of hyaluronic acids and adipose tissue in temporomandibular joint

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 28

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** After standard arthrocentesis of the temporomandibular joint

* Direct access to the buccal fat pad, is found at distobuccal depth of the maxillary tuberosity.
* It may be dissected during the resection an upper mucosal incision posterior to the second molar
* After a single scissor stab through the periosteum the (BFP)extrude into the operative site.
* Closure of the flap by suitable suture.
* Collection of lipids then manually manipulated with two syringes connecting together and pushing the lipids against each other to receive the injectable amount of micro fragmented adipose tissue .

**Intervention Names:**

- Biological: adipose tissue fragmented

**Label:** injection with adipose tissue

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Arthrocentesis of the superior joint compartment was performed in all patients under local anesthesia using the technique described by Nitzan et al.

Another 19-gauge needle was inserted into the distended compartment in the area of the articular eminence, and the superior joint space was irrigated with 200 mL saline solution, allowing a free flow through the first needle.

On termination of procedure, 2 mL commercially available hyaluronic injected into the superior compartment.

**Intervention Names:**

- Biological: adipose tissue fragmented

**Label:** injection with hyaluronic acids

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- injection with adipose tissue

- injection with hyaluronic acids

**Description:** harvested from the case form buccal pad of fat

**Name:** adipose tissue fragmented

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** by Vas measurement scale OF PAIN

**Measure:** VAS

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** degree of opening on each visit

**Measure:** mouth opening

**Time Frame:** 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* \* TMJ osteoarthritis assessed by clinical examination and MRI imaging

  * Presence of TMJ-related symptoms including at least limited mouth opening and joint pain
  * Previously failed conservative treatment
  * Age superior to 14 years
  * No previous TMJ surgical procedures
  * Acquisition of informed consent;
  * Complete availability of the data acquired preoperatively and during each follow-up
  * Patients free from any systemic disease that may affect the procedure.

Exclusion Criteria:

* \* Previously diagnosed hematological and neurological conditions;

  * Previous malignant head and neck neoplasms;
  * Contraindication to fat harvesting.
  * Uncooperative patients.

**Gender Based:** True

**Gender Description:** age superior to 14 years of age

**Minimum Age:** 14 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**Description:** Dose Lipogems injection affect TMJ derangement more than hyaluronic acid in treatment of the temporomandibular joint osteoarthritis and internal derangement?

Statement of the problem:

Internal derangement and osteoarthritis are the most common degenerative temporomandibular joint diseases and initial treatment for such conditions relies on arthrocentesis.

Micro fragmentation of adipose tissue has been proven in orthopedic literature to represent a more effective method to preserve stem cells, but no application has ever been reported in the temporomandibular joint.

**Info Types:**

- CSR

**IPD Sharing:** YES

**Time Frame:** WITH IN THIS YEAR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

### Intervention Browse Module - Browse Leaves

- ID: M9878

- Name: Hyaluronic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
