Dysgnatic patients
Conditions
Interventions
Controle = Bimaxillary osteotomy with conventional mandible-first approach using splint and stock osteosynthesis, Intervention = Bimaxillary osteotomy with patient specific osteosynthesis guided maxil
Sponsors
Department of Oral and Maxillofacial Surgery of University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is awaiting orthognathic surgical treatment, namely: bimaxillary osteotomies (upper and lower jaw) as part of their treatment plan; • The patient is at least 18 years of age. Completion of physical growth is a routine criterion for orthognathic surgery;
Exclusion criteria
Exclusion criteria: • Patient does not agree to randomized application of osteosynthesis method; • Pregnancy, which is a general contraindication for orthognathic surgery; • Known allergy to titanium • Patient is, for any reason, not able to undergo the 3D virtual planning procedure, including double dentition imprints/intra-oral scan, pre-operative CBCT scanning and virtual planning of translations. An example could be the inability to complete the dental imprint of both upper and lower jaw, or inadequate scanning of the patient. These examples will. If applicable, come up during the preparation appointment with the patient, and therefore do not delay the patient’s trajectory. • Patient has a cleft lip or cleft palate • Patient has a syndrome associated with craniofacial anomalies • The operation of the patient includes a multisegmental Le Fort 1 osteotomy of the maxilla
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the median difference between planned and realised positioning of the maxilla, measured at the level of the dentition. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary study parameter (mid-long term) is the bony relapse of the maxilla | — |
Contacts
Public ContactHylke van der Wel
UMCG
Outcome results
None listed