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Recruiting NCT06694532

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

Phase I / Phase II Interventional Temporomandibular Joint Disorders Arthrocentesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hyaluronic acid, Syringes.
Who it may be relevant to
Registry conditions: Temporomandibular Joint Disorders, Arthrocentesis. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparative Study Between the Effectiveness of High Versus Low Molecular Weight Hyaluronic Acid in TMJ Arthrocentesis

Overview

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 .

Interventions

  • Drug Hyaluronic acid
    Comparative study between Hyalgan and Hyorth injectable products in TMJ Disorders by arthrocentesis of 2 syringes device
  • Device Syringes
    Whilst you are asleep, two small needles will be inserted into the TMJ / Jaw Joint. One of these needles allows sterile saline to be pumped into the joint under pressure whilst the other needle allows the saline to drain out of the joint then injection of the HA injectiable products .

Primary outcome measures

  • EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis [Time frame: 36 months]
Secondary outcome measures (1)
  • comparative between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis [Time frame: 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Assiut Univeristy — Asyut

Identifiers

NCT: NCT06694532 · Hyaluronic and TMJ Disorders

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗