Malignat neoplasm of the gum, ffracture of mandible, fracture of orbital floor, Neoplasm of unknown or uncertain behavior of oral cavity or digestive organs, malignat neoplasm without specification of site, Other malignant neoplasm of skin, Malinant neoplasm of other and unspecified parts of the mouth, benign neoplasm of bone and articular cartilage, Dentofacial anomalies (including malocclusion), Other dieseases of jaws S02 K10 K07 D48 D16 D37 C06 C44 C80 C03
Conditions
Interventions
Group 1: 1. Column: Mandible Reconstruction
A comparison between
- new industrial custom-made mandible implants (n = 30)
- Polyamide modell bended mandible implants (n = 30, existing data)
- manually
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: older than 18 years till 99 years, reconstruction after ablative tumor surgery/ traumatically injury (pre-operativ true to original planning), intraoperative image- controlled tumor-defect-/ trauma reconstruction, existence of a pre-surgery CT or/ and FaceScan, patient letter of agreement, positive ethical review commitment, conformed clinical trial, adequate follow-up care and examination. column mandible indication for mandible fraction- resection column orbita before trauma or tumour resection: existing vision at the affected eye, indication for
Exclusion criteria
Exclusion criteria: Key exclusion criteria column mandible: a. pre-existing infection b. unstable blood circulation to the skin and oral mucosa covering the implanted material c. inflexibility in the skin and oral mucosa covering the implanted material d. any disease or abnormality contraindicating bone graft or surgery in general e. Legal incompetence f. Life- threatening condition g. Alcohol and drug abuse that prevents from a reliable study participation Key exclusion criteria column orbita: a. Bilateral orbital fracture b. Fractures of the orbital roof c. Complex zygoma fracture d. Previous dislocated orbital fractures on either side e. Vision or dipoplia not assessable f. Injury to the globe that restricts surgical reconstruction (eg, Retinal detachment, globe rupture, …) g. Neurological diseases with influence on eye motility or sight h. Legal incompetence i. Life- threatening condition j. Alcohol and drug abuse that prevents from a reliable study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ideal 3-dimensional position of the implant (yes/ no) Up to the time of last patient inclusion, the aquired data will be evaluated due the following aspects: Does show the postoperative CT-data set have the same position as preoperative planned or are there aberances? We compare this dataset with the preoperative planned data while merging the new (post-Op) -CT slices with the "old" thus planned dataset. We want to analyze if there is any nominal-actual value difference. For this analysis we use special software tools. Some important points are the deviation of orbital values, Axes and angles. Due to minimize the bias concerning the evaluation, we developed a standard method to evaluate this data. | — |
Secondary
| Measure | Time frame |
|---|---|
| Column Mandible Same position (in mm) as pre- operatively planned ), aetiology, age, sex, diagnosis, neurosensory examination, post-operativ evaluation (medication and hospital stay), adverse events, examination of the extraoral dermis and intraoral mucosa, verification of the maximum mouth opening, evaluate the existing occlusion, plate fracture rate, plate- exposition rate, infection rate, position of the dental implants, occlusion, Examination of the extraoral dermis and intraoral mucosa, Verification of the maximum mouth opening, surgery time duration (all after closing patient file by the attending doctor Column Orbita Same orbital volumina (in ml) as pre- operatively planned (from the time when the study recrution is over), aetiology, Post Op- evaluation (2 times evaluation: about one week and 12 wks after surgery): age, sex, diagnosis, pre-op. enophthalmos, pre-op. dipoplia, Time from trauma to surgery in days, Incision, post-op. enophthalmos, post-op. dipoplia, Complications, Follow up in month, ocular motility, globe postion, visual acuity, eyelid examination, neurosensory examination, fracture details, surgical details, post-operativ evaluation (medication and hospital stay), adverse events, surgery time duration. | — |
Countries
Germany
Contacts
Public ContactMajeed Rana
Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
Outcome results
None listed