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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IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Milan, Italy, 20157