Soft Tissue Prediction in Orthognathic Surgery by Making Anatomically Accurate Virtual Model

NCT ID: NCT06714747

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-11
• Study Completion Date: 2026-11-11

Brief Summary

The role of orthognathic surgery in the correction of dento-skeletal dysmorphies, whether they are Class II or Class III or asymmetries, is to improve both the function and aesthetic appearance of thepatient. Both aspects are equally important to achieve optimal results.

When the surgeon plans the surgery, he or she must therefore take into account the effects that bone displacements will have at the level of the soft tissues directly involved in the surgery, such as the maxilla and mandible. Traditionally, such surgery consists of an orthodontic presurgical phase1,2

.

Detailed Description

The role of orthognathic surgery in the correction of dento-skeletal dysmorphies, whether they are Class II or Class III or asymmetries, is to improve both the function and cosmetic appearance of the patient. Both aspects are equally important to achieve optimal results.

When the surgeon plans the surgery, he or she must therefore take into account the effects that bone displacements will have at the level of the soft tissues directly involved in the surgery, such as the maxilla and mandible. Traditionally, such surgery consists of an orthodontic presurgical phase1,2

.

The current knowledge of facial aesthetics and its changes consequent to orthognathic surgery is given by studies mainly carried out in 2-dimensions, performed using radiographs (teleradiographs of the skull in PA and LL) and standard photographic material, on which two-dimensional cephalometric and anthropometric studies have been performed. A first fragility, related to less realism, lies in the fact that these represent objects in 2-dimensions when the human body is a structure in 3-dimensions, as well as the chiurgy that is going to be performed and the resulting changes are in the 3-dimensions of space. A second lesser precision of this method of records acquisition is the substantial impossibility of obtaining comparable material in the preoperative and postoperative periods, due to the understandable difficulty of homogeneous acquisition of the records themselves: photographs and radiographs . Recent advances in technology have generated a wide variety of 3-D methods that allow acquisition in the 3-dimensions of space of both surface structures and skeletal bases. These methods include: digital stereophotogrammetry, CT, MRI, and ECO-3D.

This new knowledge has then enabled 3D studies that were previously done in 2D: cephalometry, morphological analysis of the face

. To date, commercially available simulation software manages to be fairly accurate with regard to hard tissues (bone, teeth), but not reliable enough with regard to simulation of soft tissues overlying skeletal bases and consensual motion in the face of facial hard tissue surgery, as they do not take into account the biomechanical variety of individual soft tissue components

Conditions

Orthognathic Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing orthognathic surgery and preoperative radiographic study with CBCT and MRI
• Patients with age > or = 18 years old
• Obtaining informed consent
• Patients with preoperative teleradiography and orthopantomography

Exclusion Criteria

• patients with cleft lip-palate, facial malformations and/or syndromes (syndromes with involvement of the cephalic extremity, such as sd of Apert. Cropuzon, Ofeiffer, Treacher Collins)
• patients who have undergone application of Medpor prostheses or who have undergone ancillary procedures (lipofilling, fillers, volumetric facial augmentations with insertion of polyethylene ketone prostheses)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudio Marchetti, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS - Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Claudio Marchetti, MD

Role: CONTACT

Phone: 051 214 3415

Email: claudio.marchetti@aosp.bo.it

Facility Contacts

Achille Tarsitano, MD

Role: primary

Other Identifiers

CH MAX FAC 21 01

Identifier Type: -

Identifier Source: org_study_id