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Computer Assisted Orthognathic Surgery. Facial Asymmetry

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01879969
Enrollment
20
Registered
2013-06-18
Start date
2009-12-31
Completion date
2012-01-31
Last updated
2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facial Asymmetry

Keywords

computer-assisted orthognathic surgery; facial asymmetry

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).

Interventions

PROCEDUREclassic procedure of planning

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

PROCEDUREcomputer assisted orthognathic planning and surgery of asymmetric patients

Sponsors

Università degli Studi di Sassari
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 54 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in linear measuresPreoperative (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;
Change in angular measuresPreoperative (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

MeasureTime frameDescription
age of patientsPreoperative (baseline)age at surgery
Type of surgery neededPreoperative (baseline)How many patients had genioplasty added to the standard bimaxillary surgery plan
sample sizePreoperative (baseline)number of patients
genderPreoperative (baseline)male/female

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026