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

NCT05627830 | Completed

• 1 other identifier: 111996
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• visual analogue scale

  psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients

  Change from Baseline VAS at 4 weeks ( lower score means better outcome)

• visual analogue scale

  psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients

  VAS change at 2 months ( lower score means better outcome )

Study Arms (2)

Ultrasound Guided Prolotherapy forTreatment of Internal Derangement of TMJD.

EXPERIMENTAL

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)

Procedure: Prolotherapy

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

ACTIVE COMPARATOR

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)

Procedure: Prolotherapy

Interventions

Prolotherapy PROCEDURE

Prolotherapy is an injection treatment used to relieve pain. And for Cellular Regeneration

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

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

CairoU

Cairo, Al Manial, Old Cairo, 11553, Egypt

Location

MeSH Terms

Conditions

Tinnitus; Chronic Pain; Myofascial Pain Syndromes

Interventions

Prolotherapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral & Maxillofacial Surgeon

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 28, 2022
• Study Start: November 10, 2022
• Primary Completion: May 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)