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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of previous maxillomandibular fracture

Treatment with anticoagulant drugs

Treatment with intravenous bisphosphonates

Treatment with anticonvulsants

Trial population

Patients with diagnosis of dentoskeletal disorders

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Bimaxillary Osteotomy

    Procedure/Surgery

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

Treatment groups

No treatment groups listed

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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