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Patient specific osteosynthesis in orthognatic surgery


- candidate number22493
- NTR NumberNTR5324
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jul-2015
- Secondary IDsMETc 2015/084 METC
- Public TitlePatient specific osteosynthesis in orthognatic surgery
- Scientific TitlePatient specific osteosynthesis in orthognatic surgery
- ACRONYM
- hypothesisPatient specific osteosynthesis potentially provides improved accuary of translating the maxilla to the planned position in case of orthognatic surgery. Moreover this method potentially provides more per-operative control over the movements, especially in case of a dorsal downgraft
- Healt Condition(s) or Problem(s) studiedOrthognatic surgery
- 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

- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-jul-2015
- planned closingdate1-aug-2018
- Target number of participants48
- Interventionsle fort 1 osteotomy in dysgnatic patients. Fixation of the maxilla is performed using patient specific, CAD/CAM osteosynthetic plates.
- Primary outcomeAccuracy of maxillary placement: post-operative location compared to pre-operative, 3D planned position
- Secondary outcomeSurgical satisfaction (placement, easy to use?) Relapse (after 1 year)
- Timepointspre operative planning (3-4 weeks before surgery) surgery
postop, routine control (1 week postop), including scan and 3D analysis
1 year post op routine control including scan and analysis.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Joep Kraeima
- CONTACT for SCIENTIFIC QUERIES Joep Kraeima
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryPatient specific osteosynthesis potentially provides improved accuary of translating the maxilla to the planned position in case of orthognatic surgery. Moreover this method potentially provides more per-operative control over the movements, especially in case of a dorsal downgraft
- Main changes (audit trail)
- RECORD22-jul-2015 - 24-aug-2015


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