A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures
Primary Purpose
Zygomatic Fractures
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
subtarsal approach
conventional transconjunctival approach
transconjunctival approach with Y- modification
Sponsored by
About this trial
This is an interventional treatment trial for Zygomatic Fractures
Eligibility Criteria
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.
Sites / Locations
- Faculty of Dentistry, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
subtarsal approach
conventional transconjunctival approach
transconjunctival approach with Y- modification
Arm Description
Outcomes
Primary Outcome Measures
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
esthetic appearance and scarring
Postoperative scarring was recorded as noticeable or unnoticeable
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
Secondary Outcome Measures
The duration for exposure of the fracture site
The duration from performing the incision till the field exposure calculated in minutes
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).
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05695872
Brief Title
A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures
Official Title
The Best Approach to Zygomaticomaxillary Fractures: A Comparison of Three Surgical Approaches
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zygomatic Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subtarsal approach
Arm Type
Active Comparator
Arm Title
conventional transconjunctival approach
Arm Type
Active Comparator
Arm Title
transconjunctival approach with Y- modification
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
subtarsal approach
Intervention Description
surgical approach
Intervention Type
Procedure
Intervention Name(s)
conventional transconjunctival approach
Intervention Description
surgical approach
Intervention Type
Procedure
Intervention Name(s)
transconjunctival approach with Y- modification
Intervention Description
surgical approach
Primary Outcome Measure Information:
Title
accessibility to the fracture site
Description
Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No
Time Frame
intraoperative
Title
esthetic appearance and scarring
Description
Postoperative scarring was recorded as noticeable or unnoticeable
Time Frame
6 weeks postoperative
Title
radiographic verification of adequacy of fracture reduction
Description
computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No
Time Frame
immediate postoperative
Secondary Outcome Measure Information:
Title
The duration for exposure of the fracture site
Description
The duration from performing the incision till the field exposure calculated in minutes
Time Frame
intraoperative
Title
postoperative pain
Description
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).
Time Frame
at 24 hours and 1 week
Title
sensory nerve function
Description
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
Time Frame
3 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21526
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures
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