Using custom implants in jaw surgery for better alignment
Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery: A Quality Assessment by Novel Automated Virtual Methods
This study is testing whether custom-made implants for jaw surgery can help people with jaw misalignment get better results than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark Academic / other |
| Locations | 1 site (Esbjerg) |
| Trial ID | NCT06297109 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of patient-specific implants (PSI) versus conventional mini-plates in bimaxillary orthognathic surgery for patients with mandibular retrognathia and Angle Class II malocclusion. The approach involves using 3D-printed titanium implants designed to fit the unique anatomy of each patient, which may enhance the accuracy of bone positioning during surgery. The accuracy of the surgical outcomes will be measured by comparing the actual positions of the bones post-surgery to the planned positions. This method aims to improve surgical precision and patient outcomes in jaw alignment procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with mandibular retrognathia and Angle Class II malocclusion who require bimaxillary orthognathic surgery.
Not a fit: Patients with cleft lip, craniofacial syndromes, previous trauma, or obstructive sleep apnea may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate jaw alignment and improved functional and aesthetic outcomes for patients undergoing orthognathic surgery.
How similar studies have performed: Other studies have shown promising results with the use of patient-specific implants in surgical procedures, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mandibular retrognathia * Occlusion class II * Three-piece Le Fort I osteotomy, as part of bimaxillary orthognathic surgery with or without genioplasty Exclusion Criteria: * Cleft lip * Craniofacial syndromes * Former trauma * Obstructive sleep apnea
Where this trial is running
Esbjerg
- University Hospital of Southern Denmark — Esbjerg, Denmark (Recruiting)
Study contacts
- Principal investigator: Alexandru Diaconu, m.sc. — University Hospital of Southern Denmark, Esbjerg
- Study coordinator: Michael B Holte, ph.d.
- Email: Michael.Boelstoft.Holte@rsyd.dk
- Phone: +4520645760
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.