Splintless Virtual Surgical Plan with Mandible-first Technique: 3D Accuracy Analysis

NCT06907745 | Recruiting

• 1 other identifier: Mandible First
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.

Conditions

Dentofacial Deformities

Outcome Measures

Primary Outcomes (1)

• Accuracy evaluation

  3D superposition of post-operative volumetric CT and the digital therapeutic project files. The variables and parameters analysis will be performed after the data distribution analysis, using the D'Agostino Pearson omnibus normality test: normal distribution data will be expressed as mean and standard deviation; non-normal distribution data will be expressed as median and interquartile range. The quantitative and qualitative variables will be expressed in terms of absolute frequencies and percentage value. Image superposition accuracy will be defined by measuring distances between the different anatomical reference points, considering excellent accuracy for distances less than 2 mm. Correlation and multivariate analysis models will be developed to define the secondary outcomes.

  1 month post-op

Interventions

Bimaxillary Osteotomy PROCEDURE

Maxillary LeFort I osteotomy and mandible osteotomy (BSSO) without intermediate splint.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diagnosis of dentoskeletal disorders

You may qualify if:

• Men and women
• Age over 18 and under 60
• Diagnosis of dento-skeletal dysmorphosis involving the middle third and lower part of the face
• Patients with consent to surgery
• Patients in good general health according to the evaluation of the PI and on the basis of the anamnesis and clinical examination

You may not qualify if:

• History of previous maxillomandibular fracture
• Treatment with anticoagulant drugs
• Treatment with intravenous bisphosphonates
• Treatment with anticonvulsants
• Patient's inability to maintain home hygiene standards in accordance with the study requirements
• History of drug and/or alcohol abuse
• Chronic corticosteroid therapy
• Radiotherapy, chemotherapy and/or immunosuppressive treatment or radiotherapy in the last 5 years
• Psychosis
• Pregnant or breastfeeding
• Poor compliance
• Endocrinological disorders in poor pharmacological control
• Other uncontrolled systemic conditions that preclude performing surgical procedures

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Milan, 20157, Italy

RECRUITING

MeSH Terms

Conditions

Dentofacial Deformities

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Alessandro Baj, Prof

CONTACT

00393884214136; alessandro.baj@unimi.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2024
• First Posted: April 2, 2025
• Study Start: April 24, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2025
• Last Updated: April 2, 2025

Record last verified: 2024-06

Locations

IT (1)