mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone
Procedureopen sinus lifting using bone marrow aspirate concentrate from maxillary tuberosity and mixing it with bovine bone .
NCT Number: NCT06700772
Two groups of patients with posterior vertical deficient maxillary alveolar ridge with pneumatized sinus and needing dental implant . First group will be subjected to open sinus lifting using autogenous bone mixed with bone marrow aspirate concentrate cells from maxillary tuberosity and the second group will be subjected to open sinus lifting using autogenous bone mixed with bovine bone
Interested in participating?
Request Info20 year–50 year
All sexes
Interventional
Phase 1
Faculty of oral and dental medicine - cairo university, Cairo, New Cairo, Egypt
Two groups of patients with partial edentulous posterior maxilla with pneumatized sinus and need dental implant. First group will be subjected to open sinus lifting using autogenous bone mixed with bone marrow aspirate concentrate cells from maxillary tuberosity (the study group) and the second group will be subjected to open sinus lifting using autogenous bone mixed with bovine bone (control group) Intervention Eligible patients will be equally randomized in a parallel two arm groups . The study group (open sinus lifting using bone marrow aspirate concentrate from maxillary tuberosity mixed with bovine bone) Procedure will be performed under local anesthesia A 20 gauge needle will be inserted in the maxillary tuberosity area through the palatal aspect until aspiration is positive.
Aspirate will be collected in a heparin-treated tube (2000:1) using 1ml of anticoagulant acid citrate dextrose solution for every 15ml of bone marrow aspiration.
Aspirate will be centrifuged at 3000 rpm for 10 minutes to separate the BMAC . The upper layer containing plasma and platelets will be collected using a sterile pipette, leaving the bone marrow aspirate bone marrow aspirate will be mixed with bovine bone and then the mixture will be applied in open sinus lifting Control group (open sinus lifting using autogenous bone from retromolar area mixed with bovine bone) After injection of local anesthesia a crestal incision will be carried out from a point corresponding to the occlusal surface along the external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa, parallel to the gingival margin of the mandibular molars.
The subperiosteal dissection will be extended to expose the ascending ramus and the retromolar region.
Auto chip maker bur will be used to drill out some autogenous bone particulate from retromolar which will be mixed with xenogeneic graft with a 50% to 50% ratio respectively. this mixture will be packed into the grafted site .
Post operative instructions and follow up:
Administration of:
Patient self-care instructions:
Postsurgical procedure (six months lateral sinus lifting) Local anaesthesia will be administered by infiltration or nerve block to achieve the necessary anaesthesia.
A flap will be raised at the presurgical site. A core biopsy will be harvested by introducing a core drill bit in place of an initial drill.
Sequential drilling will take place to prepare osteotomy to the right size to receive an implant.
Implant will be placed in the osteotomy with the platform flush with the bone. Flap closure will be achieved by interrupted 5-0 sutures. Outcomes Primary outcome quantity of bone gain Secondary outcome quality of bone gain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
open sinus lifting using bone marrow aspirate concentrate from maxillary tuberosity and mixing it with bovine bone .
open sinus lifting using autogenous bone from retromolar area mixed with bovine bone
Time frame: 6 months postoperative
Calculation of vertical bone gain quantity using cone beam computed tomography
Time frame: 6 months postoperative
Assessment of bone quality after open sinus lifting this bone will be harvested using trephine bur .and bone analysis will be done using H&E stain by microscope
Contact information is provided by the study sponsor or research team.
Alaa Hassan
CONTACT
Alaa Hassan, BSc
CONTACT
Cairo University
Other
Histomorphometric and Radiographic Assessment of Bone Following Maxillary Sinus Augmentation Using Bone Marrow Concentrate Cells From the Maxillary Tuberosity Mixed With Bovine Bone Versus Autogenous Bone Mixed With Bovine Bone: RCT
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