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

NCT06714747 | Recruiting

• 1 other identifier: CH MAX FAC 21 01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 .

Conditions

Orthognathic Surgery

Outcome Measures

Primary Outcomes (1)

• primary outcomes

  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).

  18 months

Secondary Outcomes (1)

• secondary outcomes

  18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Verranno arruolati 10 pazienti retrospettivamente. Per ogni paziente verranno effettuate 27 simulazioni virtuali variando le proprietà biomeccaniche delle singole parti. I dati verranno perciò analizzati su 270 interventi virtuali. Le 27 simulazioni procapite vengono determinate in base al range di variazione che in fase iniziale si decide di dare ai vari parametri biomeccanici presi in considerazione per ogni componente del modello (tessuti molli, muscoli, osso)14 . Un campione di 270 simulazione, consente di avere un intervallo di confidenza di 7.85 e un livello di confidenza del 99%. La tabella di seguito dimostra i valori massimi e minimi dati ai singoli muscoli per quanto riguarda il modulo di Young o modulo di elasticità.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS - Azienda Ospedaliero Universitaria di Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Study Officials

• Claudio Marchetti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio Marchetti, MD

CONTACT

051 214 3415; claudio.marchetti@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: January 11, 2022
• Primary Completion (Estimated): September 11, 2026
• Study Completion (Estimated): November 11, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-10

Locations

IT (1)