Comparison of the sagittal split osteotomy with and without defined inferior mandibular border osteotomy

Completed

• Conditions: mandibular splitting in longitudinal direction; sagittale split osteotomy; 10019190

• Registration Number: NL-OMON47651
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

18-50 years old
Skeletal occlusion Angle class II or III needed a surgical correction by sagittal split osteotomy.

Exclusion Criteria

Contraindications for general anaesthesia
Treated with bisphosphonates
Uncontrolled diabetes
Pregnancy
Infection
High risk of bleeding
Revision surgery
Patients under guardianship
Syndromal patients such as patients with e.g. Apert syndrome, Crouzon syndrome, hemifacial microsomia, Goldenhaar syndrome, fibrous dysplasia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is measurement of the required torque [Nm]<br /><br>that is needed to split the mandible and which is recorded during operation.<br /><br>Minor forces mean a beter prefabricated split and less chiseling by the<br /><br>surgeon.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Classification of the lingual fracture line by postoperative cone beam computed<br /><br>tomography into four classes: Fracturing according to Hunsuck (class I),<br /><br>fracturing according to Obwegeser (class II), fracturing along the mandibular<br /><br>canal (class III) and unfavourable fracture (bad split, class IV).<br /><br>Postoperative long-term sensibility of the lip, chin and oral mucosa, which is<br /><br>innervated by the inferior-alveolar nerve (Prick test, two point<br /><br>discrimination, thermal testing)</p><br>