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

NCT ID: NCT06907745

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-24

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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Conditions

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Dentofacial Deformities

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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Bimaxillary Osteotomy

Maxillary LeFort I osteotomy and mandible osteotomy (BSSO) without intermediate splint.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Milan, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro Baj, Prof

Role: CONTACT

00393884214136

Facility Contacts

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Alessandro Baj, Prof

Role: primary

0039 3884214136

Other Identifiers

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Mandible First

Identifier Type: -

Identifier Source: org_study_id

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