Computer-guided Versus Conventional Eminectomy

Not Applicable

Not yet recruiting

• Conditions: TMJ - Dislocation of Temporomandibular Joint

• Registration Number: NCT06791265
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-19
• Study First Posted: 2025-01-24
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Study Start: 2025-02-10
• Primary Completion: 2025-12-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TMJ Dislocation recurrence	six months follow up period	every patient will be asked in every follow-up visit whether he/she expressed expressed a TMJ dislocation

Secondary Outcome Measures

Name	Time	Method
Maximum interincisal opening (MIO)	six months follow up period	The amplitudes of the maximum painless mouth opening will be measured and recorded pre-operatively, immediately post-operatively, three and six months post-operatively by a millimeter graduated stainless steel ruler. The (MIO) will be measured from the inter-incisal contact point on the incisal edge of the upper central incisors to the corresponding point between the lower central incisors while motivating the patient to open his mouth widely.
Accuracy of the digital workflow	One week postoperative	The appraisal of the accuracy of the computer-guided eminectomy among the patients of the study group will adopt the incorporation of the virtual plan into the preoperative C.T. scan, followed by the superimposition of this combined arrangement over the immediate postoperative C.T. scan aided by the image registration in mimics 21.0 (Materialise, Leuven, Belgium) to calibrate the exact dimensional differences along the predetermined horizontal line of cleavage of the bony eminence in millimeters.