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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05695872
Other study ID # UAlexandriaMaxFacSurg
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 26, 2022
Est. completion date February 5, 2023

Study information

Verified date May 2023
Source University of Alexandria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is a randomized controlled clinical trial, following the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The study is intended to compare between the subtarsal approach, conventional transconjuctival approach and the Y- modification of the transconjuctival approach in the management of zygomatico-maxillay complex fracture.


Description:

The study is a randomized controlled clinical trial. Twenty-four patients with age range of 20-50 years requiring open reduction and fixation of a fractured zygomatic complex were randomly divided into three equal groups according to the approach used: Group A: subtarsal approach group. Group B: conventional transconjuctival approach group. Group C: Y- modification of the transconjuctival approach group.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 5, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Patients with ZMC fractures requiring open reduction and internal fixation. - Adult patients aged between 20 and 50 years with no gender predilection. Exclusion Criteria: - An existing laceration in the inferior and lateral periorbital site. - Infection at the fracture line. - Comminuted fracture with bone loss. - Acute and chronic conjunctival diseases.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
subtarsal approach
surgical approach
conventional transconjunctival approach
surgical approach
transconjunctival approach with Y- modification
surgical approach

Locations

Country Name City State
Egypt Faculty of Dentistry, Alexandria University Alexandria

Sponsors (1)

Lead Sponsor Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary accessibility to the fracture site Adequate exposure provided by the incision and accessiblity to proper fracture reduction and fixation was assigned as Yes or No intraoperative
Primary esthetic appearance and scarring Postoperative scarring was recorded as noticeable or unnoticeable 6 weeks postoperative
Primary radiographic verification of adequacy of fracture reduction computed tomography was requested for adequacy of fracture reduction assessment and this outcome was assigned as Yes or No immediate postoperative
Secondary The duration for exposure of the fracture site The duration from performing the incision till the field exposure calculated in minutes intraoperative
Secondary postoperative pain Pain was evaluated at 24 hours and at 1 week according to a 10-point Visual Analogue Scale (VAS), (0-1=none,2-4=mild,5-7=moderate,8-10=severe). at 24 hours and 1 week
Secondary sensory nerve function Subjective assessment of the infraorbital nerve sensation by patient questioning about any alteration in sensation at 3 months postoperatively.
Objective assessment by dental probe pressure to assess sensory changes along the distribution of the infraorbital nerve with contralateral side comparison
3 months postoperative
See also
  Status Clinical Trial Phase
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Completed NCT04719312 - Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture N/A
Not yet recruiting NCT03484676 - Adequacy of One Point Fixation of Displaced Zygomatic Complex Fracture N/A
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Recruiting NCT05438784 - Application of CAD-CAM Technology in Orbital Bone Reconstruction N/A
Completed NCT05381337 - A Method of Calculating the Shortest Incision for Internal Fixation of Zygomatic Arch Fracture N/A
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