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CompletedNCT04719312Updated Jan 22, 2021

Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture

An interventional study of Y modification of transconjunctival approach in Zygomatic Fractures, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Mar 2019, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
20 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Zygomatic Fractures

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03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 15 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    transconjunctival Y modification

    Procedure: Y modification of transconjunctival approach

Interventions

  • ProcedureY modification of transconjunctival approach

    Section of the orbital septum is done at the Arcus Marginalis and subperiosteal dissection done to expose the infraorbital rim and orbital floor. Subsequently, canthotomy of the superficial limb of the lateral canthal ligament is performed and subperiosteal dissection is carried out to expose the fracture at the frontozygomatic region. The cutaneous Y will transform into a box when retracting its corners, increasing the working area and allowing access of the frontozygomatic (FZ) suture, lateral orbital wall, body of the zygoma, infraorbital rim, and floor of the orbit with a single approach. A small upper vestibular incision is placed to expose the fracture at the zygomatic buttress. Reduction and fixation of fractures in a regular fashion are accomplished.

06

What researchers measure

Primary outcomes

  1. The exposure duration

    The time taken between performing the incision till exposure of the field

    Time frame: at the surgery

  2. 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).

    Time frame: after 1 week

  3. 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).

    Time frame: 24 hours, 48 hours, 1 week

07

Study locations

1 site
  • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
    Alexandria, Azarita 00203, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04719312
Lead sponsor
Hams Hamed Abdelrahman
Responsible party
Hams Hamed Abdelrahman (Assistant lecturer of DPH and Clinical statistician, Alexandria University) — Sponsor-investigator
First posted
Jan 22, 2021
Start date
Mar 3, 2019
Primary completion
Oct 7, 2020
Completion
Oct 7, 2020
Last update
Jan 22, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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