Status:
RECRUITING
Splintless Virtual Surgical Plan with Mandible-first Technique: 3D Accuracy Analysis
Lead Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions:
Dentofacial Deformities
Eligibility:
All Genders
Brief Summary
Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06907745
Start Date
April 24 2024
End Date
December 31 2025
Last Update
April 2 2025
Active Locations (1)
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1
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Milan, Italy, 20157