Ultrasound-Guided Vs Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. a Randomized Clinical Trial

Cairo University (CU)

Status: Completed

Conditions: TMJ Disc Disorder; Prolotherapy; Ultrasound Therapy; Complications; TMJ; Internal Derangement; Clicking Tinnitus; Pain, Chronic; Injection Site; Anterior Disc Displacement; Myofascial Pain Syndrome; Masticatory Muscle

Treatments: Procedure: Prolotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05627830

111996

Details and patient eligibility

About

Ultrasound Guided Versus Non-Guided Prolotherapy for Treatment of Internal Derangement of Temporomandibular joint.

Rationale for conducting the research:

The most critical cause for guided prolotherapy is to specify the accurate location of glenoid fossa and the disc space while prolotherapy procedure, and to adjust the needle insertion to according to articular eminence, mandibular condyle, and intra-articular space as anatomical variations. The vibration of ultrasound waves generates a heat so there is a thermal effective for prolotherapy effusion in the TMJ space.

Enrollment: 22 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients with TMD - internal derangement with symptomatic clicking pain, according to RDC (Research diagnostic criteria for TMJD) sheet .
2. Muscles spasm causing TMDs.
3. Patients who failed to improve on conservative measures or highly hyperactivity patients.
4. Female and male patients age range from 20 to 60 years old.

Exclusion criteria

1. Patients who refused to be included in the research.
2. Patients with a systemically diseases or inflammation whether local or generalized.
3. Patients with bleeding disorders.
4. Patients with unknown dextrose allergy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

Ultrasound Guided Prolotherapy forTreatment of Internal Derangement of TMJD.

Experimental group

Description:

Injection procedure in TMJ Space guided by ultrasound probe the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ). The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR)

Treatment:

Procedure: Prolotherapy

Non-Guided Ultrasound ( Blind) Prolotherapy for Treatment of Internal Derangement of TMJD.

Active Comparator group

Description:

Injection procedure in TMJ Space by anatomical land mark (blindly), and we also call it ( conventional prolotherapy ) the injection materials will be composition of ( !0% Dextrose ) + (Saline ) + (2% Lidocaine, plain anesthesia ). The intervention procedure will done after TMJ MRI assessment for patients who have anterior disc displacement with reduction (DDWR)

Treatment:

Procedure: Prolotherapy