A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures

Zygomatic Fractures Clinical Trial

Official title:

The Best Approach to Zygomaticomaxillary Fractures: A Comparison of Three Surgical Approaches

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05695872
• Other study ID #: UAlexandriaMaxFacSurg
• Status: Completed
• Phase: N/A
• Start date: August 26, 2022
• Est. completion date: February 5, 2023

Study information

• Verified date: May 2023
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 5, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Zygomatic Fractures

Intervention

Procedure:
• subtarsal approach
surgical approach
• conventional transconjunctival approach
surgical approach
• transconjunctival approach with Y- modification
surgical approach

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accessibility to the fracture site	Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No	intraoperative
Primary	esthetic appearance and scarring	Postoperative scarring was recorded as noticeable or unnoticeable	6 weeks postoperative
Primary	radiographic verification of adequacy of fracture reduction	computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No	immediate postoperative
Secondary	The duration for exposure of the fracture site	The duration from performing the incision till the field exposure calculated in minutes	intraoperative
Secondary	postoperative pain	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).	at 24 hours and 1 week
Secondary	sensory nerve function	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	3 months postoperative