Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery

Launched by ESBJERG HOSPITAL - UNIVERSITY HOSPITAL OF SOUTHERN DENMARK · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a type of jaw surgery called orthognathic surgery, which is used to correct issues with the jaw, such as retrognathia (a condition where the lower jaw is positioned further back than normal) and malocclusion (improper bite alignment). The researchers want to compare two methods of fixing the jaw: one that uses a 3D-printed guide (called a splint) and metal plates, and another that uses specially designed 3D-printed implants made of titanium. The goal is to see if the patient-specific implants (PSIs) are more accurate and stable in holding the jaw bones in place after surgery compared to the conventional method.

To be eligible for this trial, participants should have certain jaw conditions and be undergoing a specific type of jaw surgery called a three-piece Le Fort I osteotomy, which may also include chin surgery. Participants can expect to receive the standard surgical treatment as part of their orthodontic care, and the researchers will follow up with them to see how well the PSIs work over time. This study is important because it could help improve outcomes for patients needing jaw surgery by determining which method provides better results.

Gender

ALL

Eligibility 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