Computer Assisted Orthognathic Surgery. Facial Asymmetry

NCT ID: NCT01879969

Last Updated: 2013-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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).

Conditions

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Facial Asymmetry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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asymmetric patients, classic procedure

random selected

Group Type EXPERIMENTAL

classic procedure of planning

Intervention Type PROCEDURE

analysis of pictures, 2D radiographs and aesthetics; model surgery and acrylic splint

asymmetric patients, computer assisted

random selected

Group Type EXPERIMENTAL

computer assisted orthognathic planning and surgery of asymmetric patients

Intervention Type PROCEDURE

Interventions

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classic procedure of planning

analysis of pictures, 2D radiographs and aesthetics; model surgery and acrylic splint

Intervention Type PROCEDURE

computer assisted orthognathic planning and surgery of asymmetric patients

Intervention Type PROCEDURE

Other Intervention Names

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CBCT, data acquisition and processing; virtual surgery and CAD/CAM intermediate splint

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Sassari

OTHER

Sponsor Role lead

Responsible Party

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Silvio Mario Meloni

DDS, PhD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maxillofacial Unit, University of Sassari

Sassari, SS, Italy

Site Status

Countries

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Italy

Other Identifiers

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IDM 06/06/13

Identifier Type: -

Identifier Source: org_study_id

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