Computer Assisted Orthognathic Surgery. Facial Asymmetry

Study Overview
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Brief Summary
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The specific aims of the study were to measure and compare the rates of alignment and cant reduction of the dental and facial midlines among the two groups.

Detailed Description
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The purpose of this randomized, controlled, clinical study, was to evaluate the most accurate procedure for orthognathic correction of facial asymmetry. The investigators compared two different methods of surgical planning: classical (esthetic analysis of the face, cephalometric study of the skull in lateral and posteroanterior cephalograms, analysis and surgical simulation of plaster casts mounted in semi-individual articulators, development of a surgical acrylic resin intermediate splint) and digital planning (cone-beam computed tomography, data acquisition, software-assisted virtual surgery -Maxilim; Medicim, Mechelen, Belgium- and CAD/CAM processing of the surgical intermediate splint).

Conditions
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Facial Asymmetry

Intervention / Treatment
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* Procedure: classic procedure of planning
* Procedure: computer assisted orthognathic planning and surgery of asymmetric patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: facial asymmetry or mandibular deviation (cant of the occlusal plane > 3° and/or midline discrepancies > 2.5 mm) presence of all central incisors, pre- and postoperative radiographs and plaster casts (group 1) cranial CBCT images (group 2) pre- and postoperative digital photographs. Exclusion Criteria: previous trauma involving the hard or soft facial tissues functional deviation of the mandible incomplete records (CBCT, radiographs, casts or digital photographs).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: asymmetric patients, classic procedure<br>random selected | Procedure: classic procedure of planning<br>* analysis of pictures, 2D radiographs and aesthetics; model surgery and acrylic splint<br>|
| Experimental: asymmetric patients, computer assisted<br>random selected | Procedure: computer assisted orthognathic planning and surgery of asymmetric patients<br> <br> * Other names: CBCT, data acquisition and processing; virtual surgery and CAD/CAM intermediate splint;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in linear measures | More specifically were measured: distance from the upper interincisal point to the facial midline; distance from the lower interincisal point to the facial midline; distance between interincisal points; distance from skeletal menton to the facial midline; distance from soft tissue menton to the facial midline; | Preoperative (baseline)-Postoperative (up to 1 month) | 
| Change in angular measures | More specifically were measured:distance from the maxillary sagittal plane to the facial mid-sagittal plane; distance from the mandibular sagittal plane to the facial mid-sagittal plane. | Preoperative (baseline)- Postoperative (up to one month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age of patients | age at surgery | Preoperative (baseline) | 
| Type of surgery needed | How many patients had genioplasty added to the standard bimaxillary surgery plan | Preoperative (baseline) | 
| sample size | number of patients | Preoperative (baseline) | 
| gender | male/female | Preoperative (baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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computer-assisted orthognathic surgery; facial asymmetry