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Completed

NCT Number: NCT01879969

Computer Assisted Orthognathic Surgery. Facial Asymmetry

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.

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Key information

Conditions

Facial Asymmetry Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

21 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maxillofacial Unit, University of Sassari

Sassari, SS, 07100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

classic procedure of planning

Procedure

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

computer assisted orthognathic planning and surgery of asymmetric patients

Procedure

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

Primary outcomes

  1. 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;

  2. 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 outcomes

  1. age of patients

    Time frame: Preoperative (baseline)

    age at surgery

  2. Type of surgery needed

    Time frame: Preoperative (baseline)

    How many patients had genioplasty added to the standard bimaxillary surgery plan

  3. sample size

    Time frame: Preoperative (baseline)

    number of patients

  4. gender

    Time frame: Preoperative (baseline)

    male/female

Sponsors and collaborators

Lead sponsor

Università degli Studi di Sassari

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jun 18, 2013
Registry last updated
Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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