Skip to main content
Clinical Trials/NCT01879969
NCT01879969
Completed
Not Applicable

Computer Assisted Orthognathic Surgery. Facial Asymmetry

Università degli Studi di Sassari1 site in 1 country20 target enrollmentDecember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Facial Asymmetry
Sponsor
Università degli Studi di Sassari
Enrollment
20
Locations
1
Primary Endpoint
Change in linear measures
Status
Completed
Last Updated
12 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 2009
End Date
January 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Università degli Studi di Sassari
Responsible Party
Principal Investigator
Principal Investigator

Silvio Mario Meloni

DDS, PhD, Assistant Professor

Università degli Studi di Sassari

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Change in linear measures

Time Frame: 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

Time Frame: 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 Outcomes

  • gender(Preoperative (baseline))
  • age of patients(Preoperative (baseline))
  • Type of surgery needed(Preoperative (baseline))
  • sample size(Preoperative (baseline))

Study Sites (1)

Loading locations...

Similar Trials