Assessment of Concentric Needle Technique in Temporomandibular Joint (TMJ) Internal Derangement.

NCT05510336 | Unknown

• 1 other identifier: Concentric needle technique
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the effectivenes of using two concentric needles in comaprsion with the normal traditional two distant needles.

Conditions

TMJ Disc Disorder

Outcome Measures

Primary Outcomes (1)

• Pain felt during the procedure TMJ arthrocentesis

  Visual analogue scale from zero to ten (zero indicates no pain and ten indicates worst pain)

  baseline

Study Arms (2)

Study group

ACTIVE COMPARATOR

Concentric needle technique TMJ arthrocentesis using lactated ringer solution to help reduce inflammatory mediators and anterior disc discplacement with reduction

Procedure: Arthrocentesis

Control group

ACTIVE COMPARATOR

Double needle technique TMJ arthrocentesis using lactated ringer solution to help reduce inflammatory mediators and anterior disc discplacement with reduction

Procedure: Arthrocentesis

Interventions

Arthrocentesis PROCEDURE

Injection of lactated ringer solution in the TMJ to wash out inflammatory mediators and help reducing anterior disc displacement with reduction

Control group; Study group

Eligibility Criteria

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

You may qualify if:

• Patients with age ranges from 18-60.
• Patients with painful clicking.
• Patients free of systemic conditions that might affect the TMJ or interfere with carrying out the surgical procedure (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes).

You may not qualify if:

• Patients out of the specified range group
• Patients with painless TMJ clicking.
• Patients with osteo-arthritic changes of the TMJ.
• Patients with systemic conditions that might affect the TMJ or interfere with carrying out the surgical procedure (osteoarthritis, rheumatoid arthritis, uncontrolled diabetes).
• Patients with previous TMJ surgeries.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Arthrocentesis

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ahmed Adel, BDS Dentistry

CONTACT

01229530562; ahmed_adel@dentistry.cu.edu.eg

Nesrine Khairy, PHD Maxillofacial surgery

CONTACT

01002714479; nesrine.khairy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 22, 2022
• Study Start: September 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08