Patient specific osteosynthesis in orthognatic surgery

Completed

Conditions: Dysgnate afwijking
Dysgnatic malformation
over/underbite

Registration Number: NL-OMON43888

Lead Sponsor: Mondziekten, Kaak- en Aangezichtschirurgie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

• Patients are awaiting orthognatic surgical treatment, namely: Le Fort I osteotomy (upper jaw) as part of their treatment plan.;• A dorsal down graft of the maxilla, or upper jaw, must be part of the planned translocation. ;• Patients are susceptible to 3D virtual planning of their surgical intervention, e.g. their mouth opening must be sufficient for gathering a dental imprint of both upper and lower jaw at the same time. This will not require a large opening, however, when suffering from trismus it can be problematic to gather the double imprint. At least 40mm of mouth opening is usually required to gather the dentition imprint information.;• The patient is at least 18 years of age. Completion of physical growth is a routine criterion for orthognatic surgery.

Exclusion Criteria

• Patient does not agree to randomised application of osteosynthesis method;• Patient is, for any reason, not able to undergo the 3D virtual planning procedure, including double dentition imprints, 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 not delay the patients trajectory.;• Pregnancy, which is a general contraindication for orthognatic surgery.;• Allergy to titanium, which would mean a general exclusion for orthognatic surgery

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. CBCT*s of the maxillofacial region will be made according to<br /><br>care as usual in our clinic which implicates: 1 pre-operative series with<br /><br>dental impression paste, 6-10 days post-operative, and 1 year post-operative.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s): Is the application of patient specific osteosynthesis<br /><br>contributive to or at least non inferior to the surgeons* satisfaction? This<br /><br>will be registered with a standardized comparative questionnaire after each<br /><br>surgery, completed by the surgeon. This questionnaire will register the user<br /><br>friendly ness, number of switches to conventional osteosynthesis and reasons<br /><br>for switching to conventional osteosynthesis. Also the mid-long term evaluation<br /><br>(1 year post-op) provides information regarding bony relapse. The amount of<br /><br>relapse is compared between both groups. The measurements are performed<br /><br>identical to the direct post-op evaluation analysis</p><br>