Clinical trial

Histological Assessment of Deproteinized Bovine Bone Loaded by Bone Marrow Aspirate Versus Deproteinized Bovine Bone Alone for Guided Sinus Floor Elevation. (A Randomized Controlled Clinical Trial)

Name
BMAC for sinus augmentation
Description
Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone quality and quantity. Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus pneumatization were randomly divided into two equal groups: study group: the sinus membrane was elevated with BMAC/bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation. All patients will be evaluated at 1 week, 4 months to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.
Trial arms
Trial start
2022-10-30
Estimated PCD
2023-08-30
Trial end
2023-09-15
Status
Completed
Treatment
BMAC loaded on bovine graft
Bone marrow aspirate concentrate loaded on bovine graft for sinus floor augmentation
Arms:
BMAC/bovine graft
Other names:
Bone marrow aspirate concentrate loaded on bovine graft
Bovine graft only
Bovine graft only for sinus floor augmentation
Arms:
Bovine graft group
Other names:
Unloaded bovine graft
Size
12
Primary endpoint
Histological assessment
After 4 months of surgery
Eligibility criteria
Inclusion Criteria: * Patients with missing upper posterior teeth and atrophic posterior maxilla with a residual bone height ranging from 4 to 6 mm * Patients who has as deficient as 4 mm vertical bone height in posterior maxilla that need bone augmentation before delayed implant placement. * Highly motivated patients Exclusion Criteria: * Patients suffering from any systemic disease or those under any medication that may interfere with normal bone healing. * Patients suffering from any sinus pathosis. * Patients with conditions that could potentially compromise BM quality, previous BMA, or acute illness. * Heavy smoker (\> 20 cigarettes daily)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2024-02-06

1 organization

2 products

1 indication

Organization
Cairo University