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

I

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status

Enrolling

Conditions

Dentofacial Deformities

Treatments

Procedure: Bimaxillary Osteotomy

Study type

Observational

Funder types

Other

Identifiers

NCT06907745
Mandible First

Details and patient eligibility

About

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

Enrollment

28 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Alessandro Baj, Prof

Data sourced from clinicaltrials.gov

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