Computer Assisted Orthognathic Surgery. Facial Asymmetry

Facial Asymmetry Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879969
• Other study ID #: IDM 06/06/13
• Status: Completed
• Phase: N/A
• First received: June 6, 2013
• Last updated: June 18, 2013
• Start date: December 2009
• Est. completion date: January 2012

Study information

• Verified date: June 2013
• Source: Università degli Studi di Sassari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 54 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Facial Asymmetry

Intervention

Procedure:
• classic procedure of planning
analysis of pictures, 2D radiographs and aesthetics; model surgery and acrylic splint
• computer assisted orthognathic planning and surgery of asymmetric patients

Locations

Country	Name	City	State
Italy	Maxillofacial Unit, University of Sassari	Sassari	SS

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Sassari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Secondary	age of patients	age at surgery	Preoperative (baseline)	No
Secondary	Type of surgery needed	How many patients had genioplasty added to the standard bimaxillary surgery plan	Preoperative (baseline)	No
Secondary	sample size	number of patients	Preoperative (baseline)	No
Secondary	gender	male/female	Preoperative (baseline)	No