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Clinical Trials/NCT03813732
NCT03813732UnknownNot Applicable

the Effect of Using the Tyransconjunctival Approach Alone Versus Using Transconjunctival Approach Together With Lateral Canthotomy in Orbital Fractures

Cairo University2 sites in 1 country10 target enrollmentStarted: January 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
10
Locations
2
Primary Endpoint
Assessment of the esthetics

Study Overview

Brief 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.

Detailed Description

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

  1. 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,

  1. Interventions:
  2. Pre-operative phase:

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

Outcomes:

outcome Method of measurement Measuring unit Primary outcome Assessment of the esthetics. Visual analog scale Numerical Secondary outcome pain Visual analog scale Numerical (1-10)

Eligibility Criteria

Ages
15 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

orbital fracture

Other

using the trans-conjunctival approach with lateral canthotomy

Intervention: orbital fracture (Procedure)

Outcomes

Primary Outcomes

Assessment of the esthetics

Time Frame: 3 months

Visual analog scale numerical1-10

Secondary Outcomes

  • Infection(3month)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nashwa Osama

assistant researcher in national research centre

Cairo University

Study Sites (2)

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