IRCCS - Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, 40138, Italy
Location status: Recruiting
NCT Number: NCT06806605
"Dentofacial deformity refers to deviations from the norm of facial proportions and tooth ratios of such magnitude as to represent a disability." [1] These conditions afflicted two aspects of the patient's health: the first related to the functions performed by the stomatognathic apparatus (mastication, swallowing, phonation, etc...), the second related to the morphology of the face, which--by virtue of the severe disharmony of its parts--did not fully realize its function as an organ of relationships, leading the patient to high levels of psychological distress.
The nature of the dentofacial deformities was mainly related to skeletal discrepancies between the maxillae, such that the malocclusion could not be resolved by orthodontic treatment alone. The resolution of these conditions required a perfect synergy between orthodontic therapy (aimed at dental alignment of the individual arches) and surgical therapy (aimed at morphological harmonization of the face and obtaining the correct occlusion).
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Request Info18 year–60 year
All sexes
Observational
Bologna, Emilia-Romagna, 40138, Italy
Location status: Recruiting
**Orthognathic Surgery**
Orthognathic surgery allows the repositioning of the jaws in all three spatial planes. This procedure is indicated for patients with:
Orthognathic surgery has progressed rapidly since the 1950s when surgical techniques for treating most malocclusions that could not be resolved through orthodontics alone were first developed.
Subsequent technological advances have simplified the diagnosis of dentofacial deformities in three dimensions: Multislice CT (MSCT), Cone Beam CT (CBCT), Magnetic Resonance Imaging (MRI), stereophotogrammetry, dental arch scanning, software that allows surgical planning and outcome prediction, intraoperative navigation, and CAD-CAM technology. The conventional approach to orthognathic surgery (Orthodontic-first) consists of three phases: pre-surgical orthodontic treatment, the surgical phase, and post-surgical occlusion stabilization (post-surgical orthodontic treatment).
**Orthognathic Surgery and Technology: From 2D Study to 3D** To diagnose dentofacial deformities, the investigators have utilized 3D digital records created through dedicated software or devices. Real data and digital information are combined to simulate the surgical procedure.
**3D Cephalometry** Cephalometry is the method used to analyze the geometry of facial structures. Historically, this method was based on 2D radiology. The use of CT allowed the application of the same geometric criteria to 3D reconstructions of the skull and face. Studies assessing its accuracy showed that this method is comparable to standard 2D cephalometry for known measurements, but it adds a significant amount of new information, particularly regarding the rotational and translational aspects of the jaws and individual teeth.
**3D Surgical Planning** It is now possible to plan surgery using computer-assisted digital methods. The surgical plan can be transferred accurately to the patient through CAD-CAM-manufactured devices. The planning process can simulate both orthodontic and/or surgical treatment.
At the University of Bologna, the investigators have extensive experience with intraoperative navigation guided by 3D virtual simulation, combining navigation and virtual 3D surgery. they also have expertise in producing individualized CAD-CAM synthesis devices. It has been previously demonstrated that virtual orthodontic planning is as reliable as traditional methods using plaster models in orthodontic-only patients.
In fact, incorporating digital orthodontic planning into the orthodontic/surgical workflow is of great importance for the following reasons:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To analyze the orthodontic-surgical set-up carried out as part of the normal care pathway of patients operated since January 2015 and who completed treatment on May 30, 2020 in the Orthodontic First patient.
Time frame: 18 months
The primary outcome are :
analyze the surgical orthodontic set-up at time T0 (pre-treatment phase) in relation to the decompensation orthodontics actually performed and the surgery actually planned at time T1 (pre-operative phase).
Time frame: 18 months
evaluate the accuracy of the surgical orthodontic set-ups performed at time T0 and T1 in relation to the results obtained at the end of the treatment in the patient at time T2 (patient who has completed the surgical orthodontic treatment).
Time frame: 18 months
Contact information is provided by the study sponsor or research team.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
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