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Comparison of a modification of the traditional surgical technique with the traditional surgical technique that is used to break a misplaced lower jaw and set it in the correct position.


- candidate number24673
- NTR NumberNTR5982
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jul-2016
- Secondary IDsNL54299.068.15 METC 152047
- Public TitleComparison of a modification of the traditional surgical technique with the traditional surgical technique that is used to break a misplaced lower jaw and set it in the correct position.
- Scientific TitleComparison of the sagittal split osteotomy with and without defined inferior mandibular border osteotomy
- ACRONYMMandibular inferior border osteotomy
- hypothesisThe hypothesis of this study is that less torque force is necessary to achieve a complete sagittal split when using the Obwegeser Dal Pont technique with a well- defined inferior border osteotomy compared to the un-modified technique.
- Healt Condition(s) or Problem(s) studiedOrthognathic surgery, Sagittal split osteotomy, Alveolar nerve injury
- Inclusion criteria18-50 years old
Skeletal occlusion Angle class II or III needed a surgical correction by sagittal split osteotomy.
- Exclusion criteriaContraindications 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-jul-2016
- planned closingdate
- Target number of participants24
- InterventionsThis study uses the traditional technique by Obwegeser on one side of the mandible and the same technique with an additional inferior border osteotomy on the contra-lateral side (split mouth model)
- Primary outcomeTorque force needed to fracture the mandible by sagittal splitting osteotomy.
- Secondary outcomeFracture pattern of the mandible
Postoperative sensibility of the inferior alveolar nerve
- TimepointsAt time of surgery: measurements of torque forces
One day after surgery: X-ray control and classification of the mandibular fracture type
Six months after surgery: neurological examination of the inferior alveolar nerve (2 point discrimination, cold/warm, Semmes-Weinman test)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMw. Saskia van Aerssen- Lardenoije
- CONTACT for SCIENTIFIC QUERIES Roland Bockmann
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD21-jul-2016 - 11-sep-2016


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