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