A Phase 1 interventional study of mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone and mixing autogenous bone with bovine bone in Sinus Floor Elevation, sponsored by Cairo University. Recruiting at 2 sites in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Cairo University · Phase 1, Interventional, and Treatment
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
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:
Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse will be prescribed for 60 seconds two times a day for 14 days.
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
Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Under local anesthesia a 20 gauge needle that will be inserted inside tuberosity until aspiration is positive and then the aspirate will be collected in heparin treated tube (1ml anticoagulant citrate dextrose) for each 15 ml of aspirate The aspirate will be centrifuged at 3000 rpm for 10 minutes to separate the BMAC The upper layer containing the plasma and platelet will be separated using sterile peptide tube leaving the BMAC Mixing BMAC with bovine bone (2cc of bio-oss) and it will be applied in grafted sinus
Procedure: mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone
After injection of local anesthesia a crystal incision will be done from a point corresponding to occlusal surface along external oblique ridge and extending anteriorly and inferiorly through the buccal mucosa Subperiosteal dissection will be done to expose the retromolar area ACM bur will be used to collect autogenous bone and mixing it with bovine bone 50 : 50 Then this mixture will be packed into the grafted area
Procedure: mixing autogenous bone with bovine bone
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
Radiographic assessment
Calculation of vertical bone gain quantity using cone beam computed tomography
Time frame: 6 months postoperative
Histomorphometric analysis
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
Time frame: 6 months postoperative
Plan to share: No
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Cairo University