Histological Assessment of BMAC Utilized in Sinus Lift

Cairo University (CU)

Status: Completed

Conditions: Implant Site Reaction

Treatments: Drug: BMAC loaded on bovine graft; Drug: Bovine graft only

Study type: Interventional

Funder types: Other

Identifiers

NCT05730400

BMAC for sinus augmentation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

BMAC/bovine graft

Active Comparator group

Description:

Bone marrow aspirate concentrate loaded on bovine graft (Tutogen Medical GmbH, Neunkirchen am Brand, Germany, 1- 2mm particle size) utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 1st arm

Treatment:

Drug: BMAC loaded on bovine graft

Bovine graft group

Active Comparator group

Description:

bovine graft utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 2nd arm

Treatment:

Drug: Bovine graft only