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Computer Assisted Orthognathic Surgery. Facial Asymmetry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01879969
First Posted: June 18, 2013
Last Update Posted: June 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Silvio Mario Meloni, Università degli Studi di Sassari
  Purpose
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.

Condition Intervention
Facial Asymmetry Procedure: classic procedure of planning Procedure: computer assisted orthognathic planning and surgery of asymmetric patients

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Further study details as provided by Silvio Mario Meloni, Università degli Studi di Sassari:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: December 2009
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CBCT, data acquisition and processing; virtual surgery and CAD/CAM intermediate splint

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01879969


Locations
Italy
Maxillofacial Unit, University of Sassari
Sassari, SS, Italy, 07100
Sponsors and Collaborators
Università degli Studi di Sassari
  More Information

Responsible Party: Silvio Mario Meloni, DDS, PhD, Assistant Professor, Università degli Studi di Sassari
ClinicalTrials.gov Identifier: NCT01879969     History of Changes
Other Study ID Numbers: IDM 06/06/13
First Submitted: June 6, 2013
First Posted: June 18, 2013
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Silvio Mario Meloni, Università degli Studi di Sassari:
computer-assisted orthognathic surgery; facial asymmetry

Additional relevant MeSH terms:
Facies
Facial Asymmetry
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical