None listed
Conditions
Interventions
Fixing bone segments in the maxillofacial skeleton with titanium or biodegradable fixation devices.
Sponsors
Stryker Nederland
Eligibility
Inclusion criteria
Inclusion criteria: 1. patients scheduled for a solitair Le Fort I fractures, and/or; 2. patients scheduled for a solitair of multiple mandibula fracture(s), and/or; 3. patients scheduled for a solitair zygoma fracture, and/or; 4. patients scheduled for a Le Fort I osteotomy, and/or; 5. patients scheduled for a BSSO, and/or; 6. patients who signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. severe chronically ill patients (i.e.. diabetis mellites); 2. patients by whom compromised bone healing has been established (i.e. osteoporosis); 3. patients who are submerged through an infection; 4. patients who are pregnant; 5. patients who could not participate in a long follow-up (reasons); 6. patients who already have received maxillary surgery in the past (i.e,. schisis); 7. patients who are diagnosed with a psychiatric disorder (diagnosed by a psychiatrist); 8. patients who will not agree with an at random assignment to one of the treatment groups or one of the methods of treatment used in the study; 9. patients younger than 18 year regarding patients treated for fractures and patients younger that 14 regarding patients treated for osteotomies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone healing is the primary outcome measure. The definition of bone healing is: healing of the bone segments after 8 weeks without clinical and radiological signs of disturbed bone healing. Bone healing related complications are not allowed during this period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. inflammatory reaction present (redness, swelling, sensitivity, warmth, function impairment, fistula or pus drainage), assessment visual and manually; 2. seriousness inflammatory reaction (mild, serious), assessment visual and manually; 3. palpability, assessment manually; 4. dehiscence, assessment visual; 5. occlusion, assessment visual. bone formation (screw holes, fracture crevice); 6. pain, evaluated by a Visual Analogue Scale (VAS); 7. cold/warm sensitivity; 8. mandibular function, evaluated by a Mandibular Function Impairment Questionnaire (MFIQ). 9. direct costs within the de health care; 10. direct costs outside the health care; 11. indirect costs outside the health care. 12. antibiotic use; 13. analgesic use; 14. re-operation required; 15. reasons re-operations (plate/screw exposition, plat/screw fracture, loosening of plates and screws, inadequate bone healing, inadequate reduction, infection or other reasons). | — |
Contacts
Public ContactG.M. Raghoebar
University Medical Center Groningen (UMCG) Department of Oral Sugery P.O. Box 30001
Outcome results
None listed