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Clinical Trial Summary

All cases will undergo surgery under general anesthesia. Evaluation of patients with suspected orbital fracture should involve radiologic examination, motility test, diplopia field test and exophthalmometry. Plain X-ray films, although rarely used, with the Caldwell and Waters view may be done as a screening evaluation for possible fractures and foreign bodies. An orbital computed tomography, the gold standard in trauma, CT with contiguous thin axial and coronal sections should be ordered to confirm the diagnosis and plan for treatment

Postoperative care:

Proper postoperative instructions will be given the patient, in addition to the postoperative medications including antibiotics, corticosteroids and analgesics.


Clinical Trial Description

This study will be carried out on patients attending the outpatient clinic in Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University.

10. Eligibility criteria:

- Inclusion criteria:

- Age group: from 15 to 60 years old.

- Patients with pure blow-out fractures.

- Exclusion criteria:

- Patients suffering from dermatological diseases,

11. Interventions:

1. Pre-operative phase:

Patients will be subjected to:

1. Case history including personal data, medical, surgical and family history.

2. Clinical examination.

3. Preoperative anesthesia assessment for fitness for general anesthesia.

4. Treatment planning.

2. Operative phase:

All cases will undergo surgery under general anesthesia. The inferior wall can be easily accessed through transcutaneous or transconjunctival approach (with or without lateral canthotomy). The latter avoids a visible scar and is less likely to result in eyelid retraction. The medial wall can be accessed through transcaruncular approach. Careful exploration under the periosteum allows easy visualization of the fracture boundaries as well as correction of the herniated tissue.

Then various implants can be used to support the orbital soft tissue and prevent recurrent herniation. Porous polyethylene sheets (Medpor) are one of most commonly used implant materials. Other autogenous (cranial, rib or iliac bone graft) or alloplastic (gelatin film, silicone sheet, Teflon, Supramid, titanium mesh or bioresorbable copolymer plates) materials are also available.

Periocular fractures are often managed first by the ophthalmologist. With good clinical examination and radiographic imaging, an informed decision can be made whether surgical intervention is required.

3. Postoperative care:

Proper postoperative instructions will be given the patient, in addition to the postoperative medications including antibiotics, corticosteroids and analgesics. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03813732
Study type Interventional
Source Cairo University
Contact Khaled M Amr, Prof
Phone 01006029231
Email Khaledamr82@hotmail..com
Status Not yet recruiting
Phase N/A
Start date January 15, 2019
Completion date January 15, 2021

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