Clinical Trial: Computer Assisted Orthognathic Surgery. Facial Asymmetry

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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 Summary: 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).
Sponsor: Università degli Studi di Sassari

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

  • demographics [ Time Frame: Preoperative (baseline) ]
    sample size, gender, age at surgery
  • Type of surgery needed [ Time Frame: Preoperative (baseline) ]
    How many patients had genioplasty added to the standard bimaxillary surgery plan


Information By: Università degli Studi di Sassari

Dates:
Date Received: June 6, 2013
Date Started: December 2009
Date Completion:
Last Updated: June 18, 2013
Last Verified: June 2013