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Patient specific osteosynthesis in orthognatic surgery

Patient specific osteosynthesis in orthognatic surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28403
Enrollment
48
Registered
2015-07-22
Start date
2015-07-22
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Orthognatic surgery Le fort I osteotomy 3D treatment planning

Interventions

le fort 1 osteotomy in dysgnatic patients. Fixation of the maxilla is performed using patient specific, CAD/CAM osteosynthetic plates.

Sponsors

University Medical Center Groningen (UMCG)
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Accuracy of maxillary placement: post-operative location compared to pre-operative, 3D planned position

Secondary

MeasureTime frame
Surgical satisfaction (placement, easy to use?) Relapse (after 1 year)

Contacts

Public ContactJoep Kraeima

Afdeling MKA-chirurgie

j.kraeima@umcg.nlTel: 050-3613840

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)