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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-100
SponsorBasel khaled mohamed

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Muscular TMJ disorders

Bleeding tendency

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyaluronic acid

    Drug

    Comparative study between Hyalgan and Hyorth injectable products in TMJ Disorders by arthrocentesis of 2 syringes device

  • Syringes

    Device

    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 .

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: high molucular weight hyalurinic acid .Experimental treatment 2 interventions
Group B: low molcular weight hyaurinic acidExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis

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

Time frame
36 months

Secondary outcomes

1

comparative between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis

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.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Basel khaled mohamed

Lead sponsor

Assiut University

Sponsor institution