A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures
The Best Approach to Zygomaticomaxillary Fractures: A Comparison of Three Surgical Approaches
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 26, 2022
CompletedFirst Submitted
Initial submission to the registry
January 11, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2023
CompletedMay 9, 2023
May 1, 2023
5 months
January 11, 2023
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
esthetic appearance and scarring
Postoperative scarring was recorded as noticeable or unnoticeable
6 weeks postoperative
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 Outcomes (3)
The duration for exposure of the fracture site
intraoperative
postoperative pain
at 24 hours and 1 week
sensory nerve function
3 months postoperative
Study Arms (3)
subtarsal approach
ACTIVE COMPARATORconventional transconjunctival approach
ACTIVE COMPARATORtransconjunctival approach with Y- modification
ACTIVE COMPARATORInterventions
surgical approach
surgical approach
Eligibility Criteria
You may qualify if:
- Patients with ZMC fractures requiring open reduction and internal fixation.
- Adult patients aged between 20 and 50 years with no gender predilection.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, Alexandria University
Alexandria, 21526, Egypt
Related Publications (1)
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: 37542217DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Oral and Maxillofacial Surgery
Study Record Dates
First Submitted
January 11, 2023
First Posted
January 25, 2023
Study Start
August 26, 2022
Primary Completion
February 1, 2023
Study Completion
February 5, 2023
Last Updated
May 9, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share