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

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.

Study Overview

• Status: Unknown
• Conditions: Orthognathic Surgery

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 Type: Observational
• Enrollment (Anticipated): 15

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with class 2 skeletal deformity, over 18 years and younger than 40

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D soft-tissue changes (linear)	the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of soft tissue change to hard tissue change	the distance that the soft tissue has moved compared to the underlying bone, as a percentage.	6 months
Is the esthetic outcome as expected/imagined?	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.	6 months
3D soft-tissue changes (angular)	the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery	6 months
3D soft-tissue changes (volumetric)	the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: CBCT; soft tissue changes; class II,
• Other Study ID Numbers: cebd-cu-2017-04-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No