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

Orthognathic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03687307
• Other study ID #: cebd-cu-2017-04-05
• Status: Not yet recruiting
• Start date: February 2019
• Est. completion date: August 2021

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: August 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthognathic Surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D soft-tissue changes (linear)	the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery	6 months
Secondary	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
Secondary	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
Secondary	3D soft-tissue changes (angular)	the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery	6 months
Secondary	3D soft-tissue changes (volumetric)	the changes that have occurred in the soft tissue of the face after undergoing orthognathic surgery	6 months