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Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures

Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03011047
Enrollment
38
Registered
2017-01-05
Start date
2017-08-18
Completion date
2018-09-30
Last updated
2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orbital Floor Fracture

Keywords

endoscopic, trans-antral, subciliary

Brief summary

Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach versus traditional trans-orbital surgical approach (control group) in orbital blow out fractures in terms of postoperative clinical and digital radio-graphical assessments.

Detailed description

(N.M) Operator, data entry & corresponding author; Assistant lecturer , surgery department . (I.E) Main supervisor, data monitoring & auditing; Professor, surgery department. (R.H) Co-supervisor, data entry & auditing; Lecturer, surgery department . (AM) Assistant lecturer, surgery department .Faculty of Oral & Dental Medicine Cairo University outcome assessors and data collection. (YA) Assistant Lecturer of Surgery department , faculty of oral and dental medicine - Cairo University , for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents. intervention: Preoperative preparation: Preoperative cone beam CT. A clearance from the ophthalmology department after examination of papillary reflexes, motility restriction and measurement of the visual acuity. Laboratory Investigations: blood picture, liver functions, kidneys functions,coagulation profile Informed consent signed by the patient. (NM and RH) will perform all procedures under general anesthesia . Intervention :Endoscopic trans-maxillary (through the maxillary sinus) surgical approach. control group: Traditional trans-orbital surgical approaches. follow up clinically and radio-graphically for 6 months.

Interventions

PROCEDUREendoscopic trans-antral approach

new surgical approach to repair the orbital floor fractures through the maxillary sinus

PROCEDUREtrans-orbital surgical approach

through the lower eyelid below the eyelashes ,then down to bone the herniated orbital content will be reduced through this incision traditional surgical approach to repair orbital floor fractures

Sponsors

Nahla Mahmoud Awad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. Patients with unilateral/bilateral orbital blow out fractures. 2. Positive forced-duction test. ( to ensure the muscular entrapment).

Exclusion criteria

1. Medical condition affecting bone healing. 2. Medically compromised conditions, not proper candidate for general anesthesia. 3. Tumor case encroaching on the orbital floor. 4. Pathological orbital blow out fractures. 5. Allergy/ metal hypersensitivity.

Design outcomes

Primary

MeasureTime frameDescription
Diplopia resolution using Forced duction test positive/negative6 monthssubjective patient assessment

Secondary

MeasureTime frameDescription
Fracture reduction Digital radiography (Cone beam CT)6 months
Enophthalmus correction. Digital radiography (Cone beam CT)6 monthsmm

Contacts

Primary Contactnahla mahmoud awad, master
nahla.awad@dentistry.cu.edu.eg01124439776
Backup Contactreem hossameldin, PHD
reemhamdy@hotmail.com01006250787

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026