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OpenTrials
Completed

NCT Number: NCT06205667

Computer Guided Versus Conventional Arthrocentesis in Management of Internal Derangements: A Randomized Clinical Study

The aim of the study is to evaluate the applicability, accuracy, benefits and the efficacy of 3-dimensional, printed, patient-specific guides to direct TMJ access for arthrocentesis when performed in contrast with conventional arthrocentesis of TMJ.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ainshams university

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who complain from signs and symptoms of internal derangements and were diagnosed by the RDC/TMD as having disc displacement with/ without reduction with / without limitation associated with arthralgia or as having disc displacement with reduction associated with arthralgia in a presence or absence of joint sounds.
  • Patients who did not responded to conservative treatment for a minimum of 3 months.
  • Obtaining written informed consents signed by the patients.

Exclusion criteria

  • Patients suffering from any muscular disorders as myofascial pain or myofascial pain with limitations
  • If the disc was not visible in the MRI examination.
  • Patients who previously received intra-articular injection of any medication or exposed to any other TMJ invasive procedure.
  • Patients who suffer from any connective tissue diseases as rheumatoid arthritis or neurologic disorders.
  • Patients with history of major jaw trauma, bisphosphonate-derived drug use, pregnancy, alcohol or drug dependence.
  • Patients with gross mechanical restrictions or history of adhesion (fibrous or bony).
  • Patients with psychiatric disease or substance abuse or have an allergy to the substance used in the study.

Treatment and study plan

Computer Guided Arthrocentesis

Procedure

patients are going to be injected intra-articular within the superior joint space of the affected TMJ through custom guided template planned in a manner inspired by earphone design to get support from the tragus.

Conventional arthrocentesis

Procedure

patients are going to be injected intra-articular within the superior joint space of the affected TMJ using conventional method anatomical landmark determination

Primary outcomes

  1. Attempts number of needle puncture

    Time frame: intraoperative

  2. Operation time started from first needle insertion.

    Time frame: intaoperative

Secondary outcomes

  1. Maximum mouth opening

    Time frame: 1week, 1, 3 and 6

    Change of mouth opening measurement using RDC/TMD

  2. Pain reduction

    Time frame: 1week, 1, 3 and 6

    Pain assessment using Visual analogue Scale

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 16, 2024
Registry last updated
Jan 16, 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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