IRCCS - Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, 40138, Italy
Location status: Recruiting
NCT Number: NCT06714747
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
.
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Request Info18 year and older
All sexes
Observational
Bologna, Emilia-Romagna, 40138, Italy
Location status: Recruiting
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
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 18 months
Implementation of a virtual three-dimensional model of the face already provided for care procedure that is anatomically accurate in predicting soft tissue displacements following orthognathic surgery. This model will include the biomechanical characteristics of the facial muscles and skin.
In particular, the sensitivities of different areas of the face (nose, cheeks, and upper lip) that are particularly important in orthognathic surgery will be evaluated in response to variation in the biomechanical properties of the muscles (Poisson's coefficient and Young's modulus).
Time frame: 18 months
Demonstrate whether the inclusion of anatomical details such as facial muscles improves virtual prediction by comparing the simulation model with what is obtained in reality. This comparison will be made by superimposing the 3D object obtained from the virtual soft tissue simulation with the 3D soft tissue object obtained from postoperative CBCT. Through a colorimetric scale ranging from - to + 5 mm, we will evaluate the distance between the 3D reconstruction actually obtained from the patient's postoperative CBCT and the virtual simulation of the anatomically complex model.
Contact information is provided by the study sponsor or research team.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
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