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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47651
Enrollment
24
Registered
2016-05-02
Start date
2016-07-21
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mandibular splitting in longitudinal direction sagittale split osteotomy

Interventions

The sagittale split osteotomy is the worldwide standard to fracture the mandible for orthognathic reasons since 1954. It is outlined in the next paragraph: First the mandibular ramus and the mandibu

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The primary objective of the study is measurement of the required torque [Nm] that is needed to split the mandible and which is recorded during operation. Minor forces mean a beter prefabricated split and less chiseling by the surgeon.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)