Computer Assisted Orthognathic Surgery. Facial Asymmetry

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.

Study Overview

• Status: Completed
• Conditions: Facial Asymmetry
• Intervention / Treatment: Procedure: classic procedure of planning; Procedure: computer assisted orthognathic planning and surgery of asymmetric patients

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • SS
    • Sassari, SS, Italy, 07100
      • Maxillofacial Unit, University of Sassari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 54 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Università degli Studi di Sassari

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 13, 2013
• First Posted (Estimate): June 18, 2013

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: computer-assisted orthognathic surgery; facial asymmetry
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Facies; Facial Asymmetry
• Other Study ID Numbers: IDM 06/06/13