Computer Assisted Orthognathic Surgery. Facial Asymmetry
Primary Purpose
Facial Asymmetry
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
classic procedure of planning
computer assisted orthognathic planning and surgery of asymmetric patients
Sponsored by
About this trial
This is an interventional treatment trial for Facial Asymmetry focused on measuring computer-assisted orthognathic surgery; facial asymmetry
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).
Sites / Locations
- Maxillofacial Unit, University of Sassari
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
asymmetric patients, classic procedure
asymmetric patients, computer assisted
Arm Description
random selected
random selected
Outcomes
Primary Outcome Measures
Change in linear measures
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
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
age at surgery
Type of surgery needed
How many patients had genioplasty added to the standard bimaxillary surgery plan
sample size
number of patients
gender
male/female
Full Information
NCT ID
NCT01879969
First Posted
June 6, 2013
Last Updated
June 18, 2013
Sponsor
Università degli Studi di Sassari
1. Study Identification
Unique Protocol Identification Number
NCT01879969
Brief Title
Computer Assisted Orthognathic Surgery. Facial Asymmetry
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Sassari
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Asymmetry
Keywords
computer-assisted orthognathic surgery; facial asymmetry
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
asymmetric patients, classic procedure
Arm Type
Experimental
Arm Description
random selected
Arm Title
asymmetric patients, computer assisted
Arm Type
Experimental
Arm Description
random selected
Intervention Type
Procedure
Intervention Name(s)
classic procedure of planning
Intervention Description
analysis of pictures, 2D radiographs and aesthetics; model surgery and acrylic splint
Intervention Type
Procedure
Intervention Name(s)
computer assisted orthognathic planning and surgery of asymmetric patients
Other Intervention Name(s)
CBCT, data acquisition and processing; virtual surgery and CAD/CAM intermediate splint
Primary Outcome Measure Information:
Title
Change in linear measures
Description
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;
Time Frame
Preoperative (baseline)-Postoperative (up to 1 month)
Title
Change in angular measures
Description
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.
Time Frame
Preoperative (baseline)- Postoperative (up to one month)
Secondary Outcome Measure Information:
Title
age of patients
Description
age at surgery
Time Frame
Preoperative (baseline)
Title
Type of surgery needed
Description
How many patients had genioplasty added to the standard bimaxillary surgery plan
Time Frame
Preoperative (baseline)
Title
sample size
Description
number of patients
Time Frame
Preoperative (baseline)
Title
gender
Description
male/female
Time Frame
Preoperative (baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Maxillofacial Unit, University of Sassari
City
Sassari
State/Province
SS
ZIP/Postal Code
07100
Country
Italy
12. IPD Sharing Statement
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Computer Assisted Orthognathic Surgery. Facial Asymmetry
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