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Histological Assessment of BMAC Utilized in Sinus Lift

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05730400
Enrollment
12
Registered
2023-02-15
Start date
2022-10-30
Completion date
2023-09-15
Last updated
2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant Site Reaction

Keywords

Bone marrow, Sinus augmentation, Sinus lift

Brief summary

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.

Detailed description

Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus membrane augmentation on bone height gain and quality of bone on histological assessment. 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 bone marrow aspirate concentrate loaded on bovine graft whereas the control group recieved bovine graft only for sinus floor augmentation. All patients will be evaluated at 1 week, 4 months by CBCT to measure bone height and bone core biopsy for histological assessment at 4 months during implant placement.

Interventions

DRUGBMAC loaded on bovine graft

Bone marrow aspirate concentrate loaded on bovine graft for sinus floor augmentation

DRUGBovine graft only

Bovine graft only for sinus floor augmentation

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Histological assessmentAfter 4 months of surgeryHistological assessment of core biopsy obtained at time of implant placement for percentage of new bone formation and residual graft

Secondary

MeasureTime frameDescription
Implant stabilityAfter 4 months of surgeryimplant stability immediately following installation after 4 months using ostell device (ISQ scale)
Bone gainPreoperative, immediate and 4 months PostoperativeVertical bone height gain from sinus floor on cone beam ct

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026