Comparison Between Hegab Splint, Arthrocentesis, and Arthroscopy in Treatment of TMJ Closed Lock

NCT06473376 | Completed DMC

• 1 other identifier: AUAREC20200503-8
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

This prospective, randomized control study aimed to compare the Clinical Outcome of Hegab splint, Arthrocentesis, and Arthroscopy in treatment of TMJ closed lock. The study sample was derived from the population of patients who presented for evaluation and treatment of TMJ disorders.

Conditions

TMJ Disorder; TMJ Disc Disorder

Outcome Measures

Primary Outcomes (2)

• change in pain using a visual analog scale,

  The primary outcome variable was the change in pain using a visual analog scale (VAS), with 0 indicating the absence of pain and 10 indicating the worst pain possible

  one year

• improvement of maximum voluntary mouth opening

  improvement of maximum voluntary (non-assisted) mouth opening (MVMO) in millimetres.

  one year

Study Arms (3)

Group I (Control)

OTHER

Hegab TMJ splint

Procedure: arthrocentesis

Group II

OTHER

arthrocentesis

Procedure: arthrocentesis

GROUP III

OTHER

arthroscopy

Procedure: arthrocentesis

Interventions

arthrocentesis PROCEDURE

TMJ arthrocentesis and arthroscopy

Also known as: arthroscopy

GROUP III; Group I (Control); Group II

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with TMJ closed lock confirmed

You may not qualify if:

• rheumatoid arthritis psoriatic arthritis juvenile arthritis those receiving anticoagulant therapy

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Al-Azhar UNIVERSITY

Cairo, Egypt

Location

Prof.Hegab

Cairo, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Arthrocentesis; Arthroscopy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Ayman Hegab

Model Details: The patients were randomly assigned to one of the following three groups: Group I (Control): patients treated by Hegab splint. Group II: patients treated by arthrocentesis with injection of HA/PRP mix plus Hegab splint. Group III: arthroscopy with injection of HA/PRP mix plus Hegab splint. The primary outcome variable was the change in pain using a visual analog scale, and improvement of maximum voluntary mouth opening. The secondary outcome variable was the change in joint sound. The third category of variables (age and sex) was evaluated in relation to the outcomes

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: January 14, 2020
• Primary Completion: July 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)