Splintless Virtual Surgical Plan with Mandible-first Technique in Orthognathic Surgery: Tridimensional Accuracy Analysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Accuracy evaluation
Study Overview
Brief Summary
Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Accuracy evaluation
Time Frame: 1 month post-op
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.
Secondary Outcomes
No secondary outcomes reported