A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures

NCT05695872 — Not applicable, Completed, 24 participants, University of Alexandria

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

Registry	NCT05695872
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	24 (Actual)
Sponsor	University of Alexandria (Other)
Conditions	Zygomatic Fractures
Interventions	subtarsal approach, conventional transconjunctival approach, transconjunctival approach with Y- modification (Procedure)
Dates	start 2022-08-26, primary completion 2023-02-01, completion 2023-02-05, first posted 2023-01-25, last updated 2023-05-09
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions
subtarsal approach	Active comparator	Procedure: subtarsal approach
conventional transconjunctival approach	Active comparator	Procedure: conventional transconjunctival approach
transconjunctival approach with Y- modification	Active comparator	Procedure: transconjunctival approach with Y- modification

subtarsal approach (Procedure): surgical approach
conventional transconjunctival approach (Procedure): surgical approach
transconjunctival approach with Y- modification (Procedure): surgical approach

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 20 Years to 50 Years

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.

+Locations (1)

Facility	City	Country	Status
Faculty of Dentistry, Alexandria University	Alexandria	Egypt

+Publications

Results publication: Melek LN, Noureldin MG. Zygomaticomaxillary complex fractures: finding the least complicated surgical approach (A Randomized Clinical Trial). BMC Oral Health. 2023 Aug 4;23(1):539. doi: 10.1186/s12903-023-03249-8. PMID 37542217