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Chitosan-Hyaluronate Gel Mixture Vs Hyaluronic for Internal Derangement

NCT06426199 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-23

No results posted yet for this study

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

Interventions

DRUG

Chitosan-Hyaluronate Gel Mixture

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.

DRUG

Hyaluronic Acid

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.

Sponsors & Collaborators

  • Misr International University

    collaborator OTHER

  • University of Nizwa

    collaborator UNKNOWN

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2024-06-01
Completion
2024-07-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06426199 on ClinicalTrials.gov