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Computer Assisted Orthognathic Surgery. Facial Asymmetry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Silvio Mario Meloni, Università degli Studi di Sassari
ClinicalTrials.gov Identifier:
NCT01879969
First received: June 6, 2013
Last updated: June 18, 2013
Last verified: June 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Further study details as provided by Università degli Studi di Sassari:

Primary Outcome Measures:
  • Change in linear measures [ Time Frame: Preoperative (baseline)-Postoperative (up to 1 month) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    age at surgery

  • Type of surgery needed [ Time Frame: Preoperative (baseline) ] [ Designated as safety issue: No ]
    How many patients had genioplasty added to the standard bimaxillary surgery plan

  • sample size [ Time Frame: Preoperative (baseline) ] [ Designated as safety issue: No ]
    number of patients

  • gender [ Time Frame: Preoperative (baseline) ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   21 Years to 54 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879969

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

No publications provided

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
Study First Received: June 6, 2013
Last Updated: June 18, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on July 23, 2014