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 volunteersQualifiers
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
Other
Other
Treatments tested in this trial
Bimaxillary Osteotomy
Procedure/SurgeryMaxillary LeFort I osteotomy and mandible osteotomy (BSSO) without intermediate splint.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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