The Use of Biomaterials as Bone Substitute for Alveolar Cleft Patients

Tahapan Penelitian : Rekrut
Sponsor:
Mitra Pelaksana:
Material support from Department oral and maxillofacial surgery / oral pathology VU Medical Center, Amsterdam
No Registry
INA-EW74C1N
Tanggal Input Registry : 12-06-2020

09-11-2019
Primary Outcome: Safety and feasibility of biomaterial as alveolar cleft defect augmentation Parameter: clinical examination, haematology test, OPG (Orthopantomogram), CT-Scan. Timepoint: 6 months
Secondary Outcome: Bone formation and continuity of alveolar ridge Parameter: clinical examination, bone histomorphometric analysis, OPG (Orthopantomogram), CT-Scan. Timepoint: 6 months
 
The Use of Biomaterials as Bone Substitute for Alveolar Cleft Patients
The Use of Biomaterials as Bone Substitute for Alveolar Cleft Patients
Eksperimental
Intervention divided into 3 group; Group 1 : Alveolar cleft repair (gnatoplasty) with Poly-P as bone substitute, Group 2 : Alveolar cleft repair (gnatoplasty) with bone ceramic + Poly-P as bone substitute, Group 3 : Alveolar cleft repair (gnatoplasty) with bone ceramic + Microfragmented fat (MFAT) as bone substitute.
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Inclusion Criteria:

1. > 13-year-old male or female patients with alveolar bone defect 2. Patients and their families voluntarily underwent surgery, radiological examinations, and follow-up; 3. Patients and their families could read, understand and sign the relevant voluntary informed consent.

Exclusion Criteria:

1. Patients participating in other clinical study currently; 2. Patients with obvious abnormality in routine examination; 3. The heart, lungs, brain, kidneys and other vital organ function or hematopoietic function is severely impaired; 4. Patients with obvious malnutrition; 5. Patients with mental and neurological disorders that cannot follow instructions of doctors; 6. Recipient site have extensive scarring or poor blood supply caused by extensive radiotherapy or surgery or multiple trauma; 7. Patients received BMP growth factors or other bone growth promoting factor therapy; 8. Patients with a history of metabolic disease that may affect bone regeneration (such as osteoporosis, osteomalacia); 9. Patients received radiotherapy, chemotherapy, immunosuppressive or anticoagulant therapy recently; 10. Patients with systemic or local infection; 11. Patients with allergic constitution or allergic to drugs, regents or materials (PolyP) and bone ceramics used in the trial; 12. Patients with alcohol or addictive drugs dependence.
 
1063/UN4.6.4.5.31/PP36/2019
Protocol number : UH19090698
drg. Muhammad Ruslin, M.Kes., Ph.D., Sp.BM(K)