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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03687307

Enrollment

Registered

2018-09-27

Start date

2019-02-28

Completion date

2021-08-31

Last updated

2018-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthognathic Surgery

Keywords

class II,, soft tissue changes, CBCT

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results