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

• Conditions: Orthognathic Surgery

• Registration Number: NCT03687307
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-27
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-03
• Last Update Posted: 2018-10-04
• Study Start: 2019-02
• Primary Completion: 2020-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

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Exclusion Criteria

• o patients with cleft palate

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3D soft-tissue changes (linear)	6 months	the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery

Secondary Outcome Measures

Name	Time	Method
Is the esthetic outcome as expected/imagined?	6 months	using a 100mm visual analogue scale the patient will be asked to score how the aesthetic outcome measured against his expectations. 0mm is the worst score where the changes havent met the expectations at all and 100mm is where the outcome has perfectly met the expectation.
3D soft-tissue changes (angular)	6 months	the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery
Proportion of soft tissue change to hard tissue change	6 months	the distance that the soft tissue has moved compared to the underlying bone, as a percentage.
3D soft-tissue changes (volumetric)	6 months	the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery