Patient specific osteosynthesis in bimaxillary orthognathic surgery

Completed

Conditions: Dysgnate afwijking
Dysgnatic malformation
over/underbite

Registration Number: NL-OMON55189

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 88

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

• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint for this study is the geometrical change on dentition<br /><br>level. The baseline is the planned position, compared with the post-operative<br /><br>final position determined from CBCT. CBCT*s of the maxillofacial region will be<br /><br>made according to care as usual in our clinic; pre-operative, 1-wk<br /><br>post-operative, 1-yr post-operative. </p><br>

Secondary Outcome Measures