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RecruitingNCT06907745MandiFirstUpdated Apr 2, 2025

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

An observational study in Dentofacial Deformities, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Recruiting at 1 site in Italy. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
28
Sex
All
01

Study summary

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

02

Conditions studied

  • Dentofacial Deformities
03

In context

Dentofacial Deformities

39 studies on the registry are indexed under Dentofacial Deformities; 15 are open to participants now.

This study's planned enrollment of 28 is below the median of 48 across 14 observational studies indexed under Dentofacial Deformities.

Browse Dentofacial Deformities studies →

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 157 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with diagnosis of dentoskeletal disorders

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
28 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Interventions

  • ProcedureBimaxillary Osteotomy

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

06

What researchers measure

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.

    Time frame: 1 month post-op

07

Study locations

1 of 1 sites recruiting
  • IRCCS Ospedale Galeazzi-Sant'Ambrogio
    Milan, 20157, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Scientific Pubblication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06907745
Lead sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible party
Sponsor
First posted
Apr 2, 2025
Start date
Apr 24, 2024
Primary completion
Sep 30, 2024
Completion
Dec 31, 2025 (estimated)
Last update
Apr 2, 2025

Study contacts

Alessandro Baj, Prof
Contact
alessandro.baj@unimi.it
00393884214136

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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