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Recruiting Observational

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

NCT06714747 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-01-11
Last updated
2024-12-04

Condition(s) studied

Orthognathic Surgery

Study 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

.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • primary outcomes — 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).

Trial sites (1)

FacilityCityRegionStatus
IRCCS - Azienda Ospedaliero Universitaria di Bologna Bologna Emilia-Romagna Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06714747 on ClinicalTrials.gov ↗ ← All trials in Italy