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Clinical Trials/NCT03687307
NCT03687307
Unknown
Not Applicable

What Are the Three Dimensional Soft Tissue Changes That Occur After Orthognathic Surgery for Skeletal Class II Patients? Pre-test Post-test Quasi Experimental Study

Cairo University0 sites15 target enrollmentFebruary 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthognathic Surgery
Sponsor
Cairo University
Enrollment
15
Primary Endpoint
3D soft-tissue changes (linear)
Last Updated
7 years ago

Overview

Brief Summary

the aim of the study is to establish reference data that could be used for the creation of more accurate three dimensional prediction of soft tissue outcome.

Detailed Description

in this study, 15 skeletal class 2 orthognathic patients will be selected. CBCT and proface will be done preoperatively. after the surgery and 6 months later the imaging investigations will be repeated to investigate the soft tissue changes that have resulted due to the bone movement.

Registry
clinicaltrials.gov
Start Date
February 2019
End Date
August 2021
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amira Moussa

Assistant lecturer

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Patients with class II skeletal deformity
  • Patients must be over 18 years of age to allow for growth cessation
  • Patients must not have any systemic condition which contraindicates general anaesthesia

Exclusion Criteria

  • o patients with cleft palate
  • patients with syndromes affecting their craniofacial structure
  • patients with facial scars
  • patients with severe facial asymmetry

Outcomes

Primary Outcomes

3D soft-tissue changes (linear)

Time Frame: 6 months

the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery

Secondary Outcomes

  • Is the esthetic outcome as expected/imagined?(6 months)
  • 3D soft-tissue changes (angular)(6 months)
  • Proportion of soft tissue change to hard tissue change(6 months)
  • 3D soft-tissue changes (volumetric)(6 months)

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