Zygomatic Fractures Clinical Trial
Official title:
The Best Approach to Zygomaticomaxillary Fractures: A Comparison of Three Surgical Approaches
Verified date | May 2023 |
Source | University of Alexandria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
University of Alexandria |
Egypt,
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 |
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