Computer Assisted Orthognathic Surgery. Facial Asymmetry

Not Applicable

Completed

• Conditions: Facial Asymmetry
• Interventions: Procedure: classic procedure of planning; Procedure: computer assisted orthognathic planning and surgery of asymmetric patients

• Registration Number: NCT01879969
• Lead Sponsor: Università degli Studi di Sassari

Brief Summary

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

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).

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-11
• Study Completion: 2012-01
• Status Verified: 2013-06
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-18
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
asymmetric patients, classic procedure	classic procedure of planning	random selected
asymmetric patients, computer assisted	computer assisted orthognathic planning and surgery of asymmetric patients	random selected

Primary Outcome Measures

Name	Time	Method
Change in linear measures	Preoperative (baseline)-Postoperative (up to 1 month)	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;
Change in angular measures	Preoperative (baseline)- Postoperative (up to one month)	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.

Secondary Outcome Measures

Name	Time	Method
age of patients	Preoperative (baseline)	age at surgery
Type of surgery needed	Preoperative (baseline)	How many patients had genioplasty added to the standard bimaxillary surgery plan
sample size	Preoperative (baseline)	number of patients
gender	Preoperative (baseline)	male/female

Trial Locations

Locations (1)

Maxillofacial Unit, University of Sassari; 🇮🇹 Sassari, SS, Italy