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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03011047
Other study ID # CEBD-CU-2017-1-1
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 4, 2017
Last updated July 19, 2017
Start date August 18, 2017
Est. completion date September 2018

Study information

Verified date July 2017
Source Cairo University
Contact nahla mahmoud awad, master
Phone 01124439776
Email nahla.awad@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 38
Est. completion date September 2018
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
endoscopic trans-antral approach
new surgical approach to repair the orbital floor fractures through the maxillary sinus
trans-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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nahla Mahmoud Awad

Outcome

Type Measure Description Time frame Safety issue
Primary Diplopia resolution using Forced duction test positive/negative subjective patient assessment 6 months
Secondary Fracture reduction Digital radiography (Cone beam CT) 6 months
Secondary Enophthalmus correction. Digital radiography (Cone beam CT) mm 6 months
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