A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures

Not Applicable

Completed

• Conditions: Zygomatic Fractures
• Interventions: Procedure: subtarsal approach; Procedure: conventional transconjunctival approach; Procedure: transconjunctival approach with Y- modification

• Registration Number: NCT05695872
• Lead Sponsor: University of Alexandria

Brief Summary

The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.

Detailed Description

The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used:

Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.

Study Timeline

• Study Start: 2022-08-26
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-13
• Study First Posted: 2023-01-25
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-05
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patients with ZMC fractures requiring open reduction and internal fixation.
• Adult patients aged between 20 and 50 years with no gender predilection.

Exclusion Criteria

• An existing laceration in the inferior and lateral periorbital site.
• Infection at the fracture line.
• Comminuted fracture with bone loss.
• Acute and chronic conjunctival diseases.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
subtarsal approach	subtarsal approach	-
conventional transconjunctival approach	conventional transconjunctival approach	-
transconjunctival approach with Y- modification	transconjunctival approach with Y- modification	-

Primary Outcome Measures

Name	Time	Method
accessibility to the fracture site	intraoperative	Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No
esthetic appearance and scarring	6 weeks postoperative	Postoperative scarring was recorded as noticeable or unnoticeable
radiographic verification of adequacy of fracture reduction	immediate postoperative	computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No

Secondary Outcome Measures

Name	Time	Method
The duration for exposure of the fracture site	intraoperative	The duration from performing the incision till the field exposure calculated in minutes
postoperative pain	at 24 hours and 1 week	Pain was evaluated at 24 hours and at 1 week according to a 10-point Visual Analogue Scale (VAS), (0-1=none,2-4=mild,5-7=moderate,8-10=severe).
sensory nerve function	3 months postoperative	Subjective assessment of the infraorbital nerve sensation by patient questioning about any alteration in sensation at 3 months postoperatively.; Objective assessment by dental probe pressure to assess sensory changes along the distribution of the infraorbital nerve with contralateral side comparison

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt