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

NCT ID: NCT06694532

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-31

Study Completion Date

2026-02-28

Brief Summary

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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

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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 .

Conditions

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Temporomandibular Joint Disorders Arthrocentesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers
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, were included in the study.

Study Groups

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high molucular weight hyalurinic acid .

patients injected e high molucular weight hyalurinic acid .

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type DRUG

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

Syringes

Intervention Type 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 .

low molcular weight hyaurinic acid

patients injected with low molucular weight hyalurinic acid .

Group Type EXPERIMENTAL

Hyaluronic acid

Intervention Type DRUG

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

Syringes

Intervention Type 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 .

Interventions

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Hyaluronic acid

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

Intervention Type DRUG

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 .

Intervention Type DEVICE

Other Intervention Names

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Arthrocentesis Arthrocentesis

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Basel khaled mohamed

OTHER

Sponsor Role lead

Responsible Party

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Basel khaled mohamed

Assistant Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Basel K Mohamed

Role: PRINCIPAL_INVESTIGATOR

Assiut Univeristy

Locations

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Assiut Univeristy

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Basel K Mohamed

Role: CONTACT

+201099848089

Basel K Mohamed

Role: CONTACT

+201099848089

Facility Contacts

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Basel K Mohamed

Role: primary

Other Identifiers

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Hyaluronic and TMJ Disorders

Identifier Type: -

Identifier Source: org_study_id

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