Clinical trial NCT06791265: Computer-guided Versus Conventional Eminectomy
Official title: Computer-guided Versus Conventional Eminectomy for Treatment of Recurrent Temporomandibular Joint Dislocation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: TMJ - Dislocation of Temporomandibular Joint
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Temporomandibular joint (TMJ) dislocation represents a non-self-limiting condylar hypermobility due to its displacement from the glenoid fossa, most commonly in an anteromedial non-functional positional stuck.

The pathogenesis of (TMJ) dislocation is multifactorial, as the topography of the bony eminence, ligamentous and capsular laxity, muscular hyperaction or discoordination, as well as the presence of occlusal disturbance, would all contribute to its incidence, with a typical presentation of pain, open mouth, and masticatory muscle spasms

Detailed description: The surgical treatment modalities of the recurrent anteromedial condylar dislocation are directed to ligamentous, musculature, and bony alteration. Since it was first described by Myrhaug in 1951, Eminectomy has been recognized as the gold standard and the salvage surgical intervention for the management of recurrent condylar dislocation by the unrestricted free posterior translation of the mandibular condyle after the elimination of the bony interference by the excision of the obstructing eminence. However, the procedure carries out the potential risks of dislocation recurrence as the attention is usually directed to the excision of the lateral aspect of the bony eminence rather than its anteromedial extension and the anterior portion of the glenoid fossa or the invasion of the middle cranial fossa as a result of excessive unplanned bone removal, fracture propagation due to improper surgical technique, or eminence pneumatization

The current study designates a randomized controlled clinical trial that compares an eminectomy-based computer-guided digital workflow versus a free-hand conventional eminectomy for the treatment of patients with bilateral recurrent (TMJ) dislocation concerning the recurrence rate as a primary outcome and the Maximum interincisal opening (MIO) as a secondary outcome, stating a null hypothesis that the digital workflow is indifferent to the conventional technique regarding recurrence rate and (MIO). Furthermore, the study assesses the accuracy of the innovative digital workflow within the computer-based eminectomy group.

Eligibility criteria: Inclusion Criteria:

1. Patients with an age range of 18-60 years with no sex predilection, with bilateral recurrent episodes of condylar dislocation of a minimum of three per month with previously failed conservative management.
2. Proper general health and medically classified as ASA I or ASA II.

Exclusion Criteria:

1. The patients with unilateral condylar dislocation, facial nerve motor functional affection, and those with the radiographic interpretation of pneumatized articular eminence or zygomatic arch.
2. ASA III medically classified patients and those with a history of previous (TMJ) surgery.

Primary outcomes:
measure: TMJ Dislocation recurrence
timeFrame: six months follow up period
Secondary outcomes:
measure: Maximum interincisal opening (MIO)
timeFrame: six months follow up period
measure: Accuracy of the digital workflow
timeFrame: One week postoperative
Other outcomes:
Locations:
Study officials:
References: