Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 100Years
All Genders
ID06694532

Comparative Study of High Versus Low Molecular Weight Hyaluronic Acid Injections in TMJ Arthrocentesis for Temporomandibular Joint Disorders

Led by Basel khaled mohamed · Updated on 2024-11-19

30

Participants Needed

1

Research Sites

3 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of high molecular weight versus low molecular weight hyaluronic acid injections after two-needle arthrocentesis in patients aged 17 to 70 years with painful symptoms and internal derangement of the temporomandibular joint (TMJ) that has not improved after conservative treatment. The goal is to compare how these injections improve pain, mouth opening, and joint noises such as clicking or cracking. Participants will be divided into two groups: one receiving injections of high molecular weight hyaluronic acid and the other receiving low molecular weight hyaluronic acid. The procedure involves inserting two small needles into the TMJ while the patient is asleep; sterile saline is pumped into the joint and drained out, followed by injection of the assigned hyaluronic acid product. This randomized study uses a single-blind design to compare the two treatments. During the study, patients will be assessed for improvements in pain severity on a scale of 1 to 10, range of mouth opening measured in millimeters, and the presence or absence of joint noises such as clicking and cracking. The primary outcome is the efficacy of the injections over a 36-month period. Safety and symptom improvements will be monitored through clinical examinations and patient reports throughout the study duration.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Muscular TMJ disorders
  • Bleeding tendency

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants undergo arthrocentesis with injection of either high or low molecular weight hyaluronic acid to treat temporomandibular joint disorders.

1 treatment visit (in-person)

Follow-up

Duration - Up to 36 months

Participants are monitored for up to 36 months to assess the efficacy and safety of the hyaluronic acid injections.

Periodic follow-up visits up to 36 months

Trial Site Locations

Total: 1 location

1

Assiut Univeristy

Asyut, Egypt, 12346

Actively Recruiting

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Research Team

B

Basel K Mohamed

B

Basel K Mohamed

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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