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Completed

NCT Number: NCT06667791

Computer Guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint

Background: The intra-articular injection is considered the first line of minimally invasive treatment in TMJ-ID patients who do not respond to conservative treatment. Image-guided puncture technique has emerged to add safety, reliability, convenience, and decrease the need for correcting the puncture point.

Aim of the study: To evaluate the feasibility and clinical outcomes of computer-guided superior joint space injection of sodium hyaluronate in the treatment of temporomandibular joint disorder (TMJ-ID) compared with conventional injection

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic of Oral and Maxillofacial Surgery

Alexandria, 00302, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1. Patients diagnosed with internal derangement according to Wilkins stage I and II.
  • Patients who would not respond to conservative treatment as a first line of treatment.

Exclusion criteria

  • Patients with Wilkins stage III, IV, V.
  • History of mandibular fracture.
  • Lactating, pregnant or planning pregnancy women.
  • Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.

Treatment and study plan

Computer guided sodium hyaluronate injections

Other

Patients will be treated with Computer guided sodium hyaluronate injections in superior TMJ space

conventional sodiumhyaluronate injections

Other

Patients will be treated with conventional sodium hyaluronate injections in superior TMJ space

Primary outcomes

  1. Change in TMJ dysfunction

    Time frame: Baseline, 1 month, and 3 months

    A modified version of Helkimo's clinical dysfunction index (Di) is be calculated to assess the TMJ dysfunction as follows:

    • Maximum unassisted mouth opening range: Opening range will be determined by asking the patient to gently open mouth and measure the distance between upper and lower central incisors.
    • Mandibular deviation during opening: Patients will be asked to open mouth gently and deviation will be noted between maxillary and mandibular midline, score 0 - if <2 mm, score 1 - if 2-5 mm, and score 5 - if >5 mm

  2. change in pain score

    Time frame: Baseline,1 months, and 3 months

    Pain level was determined by the patient's self-assessment using a visual analog scale (VAS) from zero to 10 ("0" is pain-free and "10" is severe intolerable pain).

Secondary outcomes

  1. Duration of operation

    Time frame: Baseline

    Total procedural time consumed starting from the application of topical antiseptic up to the end of the procedure.

  2. Number of Needle Relocation

    Time frame: Baseline

    The need to relocate the needle after first puncture of both needles will be used to compare between the efficacies of the computer guided arthrocentesis guide and the conventional free hand arthrocentesis.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

Evaluation of Computer-guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint (a Randomized Controlled Clinical Trial)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2024
Registry last updated
Oct 31, 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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