Status:
COMPLETED
Comparison of Calcium Phosphate Cement With Patient-specific Implants for Cranial Reconstruction
Lead Sponsor:
AZ Sint-Jan AV
Conditions:
Cranial Defect
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Background Cranial reconstruction after monocortical bonegraft harvesting remains a clinical challenge for the maxillofacial surgeon. At present, there is no gold standard technique advised. Patient-s...
Eligibility Criteria
Inclusion
- patients aged 18 years or older
- patients of all genders
- patients with moderate to extreme bone atrophy of the jaw, caused by periodontitis or edentulism
- patients requiring a full reconstruction (both anterior and posterior region)
- patients receiving their surgery and follow-up care at the AZ Sint-Jan Brugge-Oostende AV
- patients providing written informed consent
Exclusion
- \- Patients not eligible according to abovementioned criteria
- Patients with severe uncontrolled diabetes
- Patients with contraindications for general anesthesia
- Patients with known allergies to the biomaterials used
- Patients with cranial vault without diploe and/or cranial vault thickness \<3mm, as defined with cone-beam CT
- Patients with previous surgery of the skull region
- Patients with an explicit risk of bleeding from cranial venous structures, as described by the radiologist based on his/her evaluation of the preoperative CBCT
Key Trial Info
Start Date :
June 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03841643
Start Date
June 21 2017
End Date
December 31 2018
Last Update
June 19 2019
Active Locations (1)
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1
Department MKA, AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium