A Comparison of Three Surgical Approaches to Zygomaticomaxillary Fractures
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: subtarsal approach
|
Procedure: subtarsal approach
surgical approach
|
| Active Comparator: conventional transconjunctival approach
|
Procedure: conventional transconjunctival approach
surgical approach
|
| Active Comparator: transconjunctival approach with Y- modification
|
Procedure: transconjunctival approach with Y- modification
surgical approach
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Dentistry, Alexandria University | Alexandria | Egypt | 21526 |
Sponsors and Collaborators
- University of Alexandria
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UAlexandriaMaxFacSurg