EffIcacy Between Arthrocentesis With High Versus Low Molecular Weight Hyaluronic Acid in Treatment of TMJ Disorders

Phase 1

Recruiting

• Conditions: Temporomandibular Joint Disorders; Arthrocentesis
• Interventions: Drug: Hyaluronic acid; Device: Syringes

• Registration Number: NCT06694532
• Lead Sponsor: Basel khaled mohamed

Brief Summary

The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment.

Detailed Description

The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.

, 1- significantly improving the pain on scale 1-10 , and 2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.

3-The presence of absence of clicking and cracking in jaw .

Study Timeline

• Study First Submitted: 2023-10-30
• Study Start: 2023-10-31
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Study First Posted: 2024-11-19
• Last Update Posted: 2024-11-19
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Pain or tenderness of the jaw
• Pain in one or both of the temporomandibular joints
• Aching pain in and around your ear
• Difficulty chewing or pain while chewing
• Aching facial pain
• Locking of the joint,

Exclusion Criteria

• Muscular TMJ disorders
• Bleeding tendency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high molucular weight hyalurinic acid .	Hyaluronic acid	patients injected e high molucular weight hyalurinic acid .
high molucular weight hyalurinic acid .	Syringes	patients injected e high molucular weight hyalurinic acid .
low molcular weight hyaurinic acid	Hyaluronic acid	patients injected with low molucular weight hyalurinic acid .
low molcular weight hyaurinic acid	Syringes	patients injected with low molucular weight hyalurinic acid .

Primary Outcome Measures

Name	Time	Method
EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis	36 months	The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.; , 1- significantly improving the pain on scale 1-10 , and

Secondary Outcome Measures

Name	Time	Method
comparative between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis	36 months	The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.; 2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.

Trial Locations

Locations (1)

Assiut Univeristy; 🇪🇬 Assiut, Egypt