3D accuracy analysis of a new surgical planning technique for jaw surgery
Splintless Virtual Surgical Plan with Mandible-first Technique in Orthognathic Surgery: Tridimensional Accuracy Analysis
This study is testing a new way to plan jaw surgery without using splints to see if it helps improve the accuracy of the surgery for patients with jaw deformities.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 28 (estimated) |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT06907745 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the accuracy of a splintless virtual surgical plan using a mandible-first technique for patients with dentofacial deformities. It involves a three-dimensional superposition of post-operative volumetric CT scans and digital therapeutic project files to assess surgical outcomes. The study aims to improve surgical precision and patient outcomes in jaw surgery. Participants will undergo bimaxillary osteotomy as part of their treatment.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 to 60 with a diagnosis of dento-skeletal dysmorphosis affecting the middle and lower face who are in good general health.
Not a fit: Patients with a history of maxillomandibular fractures, those on anticoagulant or certain other medications, or those with uncontrolled systemic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of surgical planning and improve recovery outcomes for patients with dentofacial deformities.
How similar studies have performed: While this specific approach is novel, similar studies assessing surgical accuracy in jaw surgery have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan, Milan
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro Baj, Prof
- Email: alessandro.baj@unimi.it
- Phone: 00393884214136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.