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

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627830
• Other study ID #: 111996
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: February 2023
• Source: Cairo University
• Contact: Tarek Abdallah EL-Ghareeb, M.D.
• Phone: 00201227418235
• Email: t.elghareeb[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Injection Site
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Pain, Chronic
• Tinnitus
• TMJ
• TMJ Disc Disorder
• Ultrasound Therapy; Complications

Intervention

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

Locations

Country	Name	City	State
Egypt	CairoU	Cairo	Al Manial, Old Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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 )