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NCT Number: NCT06473376

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

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.

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Key information

Conditions

TMJ Disorder Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases TMJ Disc Disorder Temporomandibular Joint Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar UNIVERSITY, Cairo, Egypt

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About this study

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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with TMJ closed lock confirmed

Exclusion criteria

  • rheumatoid arthritis psoriatic arthritis juvenile arthritis those receiving anticoagulant therapy

Treatment and study plan

Arthrocentesis

Procedure

TMJ arthrocentesis and arthroscopy

Other names: arthroscopy

Primary outcomes

  1. change in pain using a visual analog scale,

    Time frame: one year

    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

  2. improvement of maximum voluntary mouth opening

    Time frame: one year

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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: arthroscopy

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 25, 2024
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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