Computer Assisted Orthognathic Surgery. Facial Asymmetry

NCT01879969 | Completed

• 1 other identifier: IDM 06/06/13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Facial Asymmetry

Keywords

computer-assisted orthognathic surgery; facial asymmetry

Outcome Measures

Primary Outcomes (2)

• 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;

  Preoperative (baseline)-Postoperative (up to 1 month)

• 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.

  Preoperative (baseline)- Postoperative (up to one month)

Secondary Outcomes (4)

• age of patients

  Preoperative (baseline)

• Type of surgery needed

  Preoperative (baseline)

• sample size

  Preoperative (baseline)

• gender

  Preoperative (baseline)

Study Arms (2)

asymmetric patients, classic procedure

EXPERIMENTAL

random selected

Procedure: classic procedure of planning

asymmetric patients, computer assisted

EXPERIMENTAL

random selected

Procedure: computer assisted orthognathic planning and surgery of asymmetric patients

Interventions

classic procedure of planning PROCEDURE

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

asymmetric patients, classic procedure

computer assisted orthognathic planning and surgery of asymmetric patients PROCEDURE

Also known as: CBCT, data acquisition and processing; virtual surgery and CAD/CAM intermediate splint

asymmetric patients, computer assisted

Eligibility Criteria

• Age: 21 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• previous trauma involving the hard or soft facial tissues
• functional deviation of the mandible
• incomplete records (CBCT, radiographs, casts or digital photographs).

Sponsors & Collaborators

• Università degli Studi di Sassari: lead

Study Sites (1)

Maxillofacial Unit, University of Sassari

Sassari, SS, 07100, Italy

Location

MeSH Terms

Conditions

Facial Asymmetry

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Assistant Professor

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 18, 2013
• Study Start: December 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

IT (1)