Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Antibiotics (Amoxicillin 1g twice daily for 5 days) to prevent any chance of infection.
Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days) to avoid any chance of edema or pain or swelling
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open sinus lifting using bone marrow aspirate from maxillary tuberosity mixed with bovine bone | Experimental | 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 |
|
| Open sinus lifting using autogenous bone mixed with bovine bone | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mixing bone marrow aspirate concentrate from maxillary tuberosity with bovine bone | Procedure | open sinus lifting using bone marrow aspirate concentrate from maxillary tuberosity and mixing it with bovine bone . |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic assessment | Calculation of vertical bone gain quantity using cone beam computed tomography | 6 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months postoperative |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaa Hassan, BSc | Contact | 01026980299 | Alaa.abdullah@dentistry.cu.edu.eg | |
| Alaa Hassan | Contact | 01026980299 | Alaamegahed@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohammed Mounir shaker | Faculty of oral and dental medicine cairo university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of oral and dental medicine - cairo university | Recruiting | Cairo | New Cairo | 12613 | Egypt |
Not provided
| Label | URL |
|---|---|
| Human maxillary tuberosity and jaw periosteum as sources of osteoprogenitor cells for tissue engineering. | View source |
| Stem cells in dentistry--part I: stem cell sources. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Randomized clinical trial A trial will be conducted in hospital of oral and maxillofacial surgery department.faculty of oral and dental medicine Cairo university Equal randomization of participant Both groups receiving treatment Each group of patient receiving a single treatment simultaneously
Not provided
Not provided
None. Because the two interventions used in this trial are clearly different and can be easily recognized by the participant and investigator
Not provided
| mixing autogenous bone with bovine bone | Procedure | open sinus lifting using autogenous bone from retromolar area mixed with bovine bone |
|
| Faculty of oral and dental medicine - cairo university | Recruiting | Cairo | 12613 | Egypt |
|