|- candidate number||22493|
|- NTR Number||NTR5324|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-jul-2015|
|- Secondary IDs||METc 2015/084 METC|
|- Public Title||Patient specific osteosynthesis in orthognatic surgery|
|- Scientific Title||Patient specific osteosynthesis in orthognatic surgery|
|- hypothesis||Patient 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) studied||Orthognatic 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 received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||22-jul-2015|
|- planned closingdate||1-aug-2018|
|- Target number of participants||48|
|- Interventions||le fort 1 osteotomy in dysgnatic patients. Fixation of the maxilla is performed using patient specific, CAD/CAM osteosynthetic plates.|
|- Primary outcome||Accuracy of maxillary placement: post-operative location compared to pre-operative, 3D planned position|
|- Secondary outcome||Surgical satisfaction (placement, easy to use?)
Relapse (after 1 year)|
|- Timepoints||pre operative planning (3-4 weeks before 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|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Joep Kraeima|
|- CONTACT for SCIENTIFIC QUERIES|| Joep Kraeima|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||Patient 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)|
|- RECORD||22-jul-2015 - 24-aug-2015|