Chitosan-Hyaluronate Gel Mixture Vs Hyaluronic for Internal Derangement

NCT06426199 | Unknown Phase 4

• 1 other identifier: 12345asdfg
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess the impact of injecting sodium hyaluronic acid versus a chitosan-hyaluronate hybrid gel into the upper compartment of the temporomandibular joint (TMJ) as a treatment for anterior disc displacement without reduction. The study will include patients diagnosed with Stage III or IV TMJ internal derangement (anterior disc displacement without reduction), as classified by Wilkes, with diagnoses confirmed through clinical symptoms and MRI evaluations. Participants will be randomly divided into two groups, both undergoing TMJ arthroscopy. In the first group, 2 ml of chitosan-hyaluronic acid hybrid gel will be injected into the affected joints, whereas in the second group, 2 ml of hyaluronic acid (HA) will be administered. The study will compare and analyze outcomes in both groups, focusing on pain during TMJ function, clicking sounds, the extent of maximum mouth opening, and maximum lateral jaw movement.

Conditions

TMJ Disc Disorder

Keywords

TMD; Hyaluronic acid; Chitosan; Arthroscopy; Intra Articular Injection; TMJ

Outcome Measures

Primary Outcomes (4)

• Joint Pain

  Self-pain and function of the jaw assessment, with Visual Analogue Scale (VAS), ranging from 0 to 10 scales. This scale will be used for self-evaluation of the patients, to evaluate pain level and jaw dysfunction and compared with preoperative degree. Patients will be asked about the pain severity \& dysfunction according to the VAS.

  3 months

• lateral excursion

  Maximum lateral excursion, the distance from midline of upper \& lower jaw will be measured with a digital caliper in mm.

  3 months

• TMJ sounds

  measured by asking the patients to open and closed his mouth several times and clicking was recorded as present (early clicking, late clicking) or absent.

  3 months

• Maximum mouth opening

  Maximum mouth opening (MMO), between upper \& lower incisors will be measured during maximum opening with a digital caliber in mm.

  3 months

Study Arms (2)

Intra-Articular Injection of Hyaluronic Acid

ACTIVE COMPARATOR

Arthroscope-guided intra-articular injection of Hyaluronic Acid in patients with TMJ anterior disc displacement without reduction.

Drug: Hyaluronic Acid

Intra-Articular Injection of chitosan-hyaluronate gel mixture

ACTIVE COMPARATOR

Arthroscope-guided intra-articular injection of chitosan-hyaluronate gel mixture in patients with TMJ anterior disc displacement without reduction

Drug: Chitosan-Hyaluronate Gel Mixture

Interventions

Chitosan-Hyaluronate Gel Mixture DRUG

The operation will be under GA. TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. The injection of 2 ml of Chitosan-Hyaluronate Gel Mixture into affected joints will be performed. Needles will be removed after the injection sites and covered its sites with gauze dressing.

Intra-Articular Injection of chitosan-hyaluronate gel mixture

Hyaluronic Acid DRUG

The operation will be under GA. TMJ arthroscopy will performed by the same TMJ arthroscopy surgeon. Lysis and lavage will be performed in the upper joint space in all cases based on the triangulation technique with an inferolateral approach. The arthroscopic procedure will include lysis of adhesions, lavage, manipulation, and debridement of the upper joint space. A 1.9-mm arthroscope with a video monitoring and recording system and a 2.2-mm protective cannula sheath will be used for TMJ arthroscopy. Ringer's lactate will be used as irrigation fluid. Both groups will receive the same arthroscopic treatments. The injection of 2 ml of Hyaluronic acid into affected joints will be performed. Needles will be removed after the injection sites and covered its sites with gauze dressing.

Intra-Articular Injection of Hyaluronic Acid

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients were diagnosed with TMJ internal derangement (anterior disk displacement without reduction Stage III, Stage IV Wilkes classification) based on clinical symptoms and MRI evaluations.
• Age 25 - 50 years old.

You may not qualify if:

• Hematological or neurological diseases.
• Inflammation or connective tissue diseases.
• Head and neck malignancies.
• History of treatment of TMJ disease or history of craniofacial surgery not related to ID treatment.
• Insufficient clinical and MRI data.

Sponsors & Collaborators

• Ain Shams University: lead
• Misr International University: collaborator
• University of Nizwa: collaborator

Study Sites (1)

Suez University

Suez, 41522, Egypt

RECRUITING

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Nehal IA Shobair, PhD

CONTACT

00201063666985; nehal.shobair@miuegypt.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 23, 2024
• Study Start: January 17, 2024
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)