Zygomatic Fractures Clinical Trial
Official title:
Evaluation of Modification of the Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture
Verified date | January 2021 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
this study was made on fifteen patients who will undergo fracture repair of the zygomaticomaxillary complex. Postoperative patient evaluation performed with specific attention paid towards, accessibility the exposure duration(time from incision till exposure of the field), esthetic appearance, post-operative pain, post-operative edema, orbital movement, wound healing, scarring infection, and the post-operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion. Postoperative clinical examinations along with radiographic examination was done to evaluate the position of zygoma and determine the adequacy of fracture reduction.
Status | Completed |
Enrollment | 15 |
Est. completion date | October 7, 2020 |
Est. primary completion date | October 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility | Inclusion criteria - Patients with ZMC fractures that requires open reduction with internal fixation. - Adult patient between 20 and 50 years with no gender predilections. Exclusion criteria - Existing lacerations in the inferior and lateral periorbital regions. - Comminuted fracture with bone loss. - Existence of infection at the fracture line. - Presence of Acute and chronic conjunctival diseases. |
Country | Name | City | State |
---|---|---|---|
Egypt | Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt | Alexandria | Azarita |
Lead Sponsor | Collaborator |
---|---|
Hams Hamed Abdelrahman |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The exposure duration | The time taken between performing the incision till exposure of the field | at the surgery | |
Primary | postoperative edema | the postoperative edema was categorized subjectively into mild (just noticeable), mild to moderate (more obvious edema without occlusion of palpebral fissure), moderate to severe (edema partially occluding palpebral fissure), and severe (edema totally occluding palpebral fissure). | after 1 week | |
Primary | change in postoperative pain | assessed through a 10-point Visual Analogue Scale (VAS),(34) (0-1=none,2-4=mild,5-7=moderate,8-10=severe). | 24 hours, 48 hours, 1 week |
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