Histological Assessment of BMAC Utilized in Sinus Lift

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Implant Site Reaction

Intervention / Treatment
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* Drug: BMAC loaded on bovine graft
* Drug: Bovine graft only


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BMAC/bovine graft<br>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 | Drug: BMAC loaded on bovine graft<br>* Bone marrow aspirate concentrate loaded on bovine graft for sinus floor augmentation<br>* Other names: Bone marrow aspirate concentrate loaded on bovine graft;|
| Active Comparator: Bovine graft group<br>bovine graft utilization for sinus floor augmentation with residual alveolar bone height less than 5 mm, 2nd arm | Drug: Bovine graft only<br>* Bovine graft only for sinus floor augmentation<br>* Other names: Unloaded bovine graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological assessment | Histological assessment of core biopsy obtained at time of implant placement for percentage of new bone formation and residual graft | After 4 months of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability | implant stability immediately following installation after 4 months using ostell device (ISQ scale) | After 4 months of surgery | 
| Bone gain | Vertical bone height gain from sinus floor on cone beam ct | Preoperative, immediate and 4 months Postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone marrow, Sinus augmentation, Sinus lift