Comparison of Deproteinized Bovine Bone Mixed With Injectable Platelet Rich Fibrin Versus a Sole Deproteinized Bovine Bone TUTOGEN BONE in Sinus Floor Elevation With Simultaneous Implant Placement. A Randomized Clinical Trial

Study Overview
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Brief Summary
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28 recruited patients indicated for sinus floor elevation with simultaneous implant placement . they were divided into two groups. first group was assigned for placement of deproteinized bovine bone solely, while the other group was assigned for the placement of mixture of injectable platelet rich fibrin with deproteinized bovine bone into the sinus after implant placement.

Official Title
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Comparison of Deproteinized Bovine Bone Mixed With Injectable Platelet Rich Fibrin Versus a Sole Deproteinized Bovine Bone TUTOGEN BONE in Sinus Floor Elevation With Simultaneous Implant Placement. A Randomized Clinical Trial.

Conditions
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Sinus Floor Elevation

Intervention / Treatment
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* Procedure: sinus lift, implant placement, sole bovine bone
* Procedure: sinus lift, implant placement, injectable PRF + bovine bone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring implants in maxilla and have atrophic bone regarding the length due to sinus pneumatiztion. Length 3: 7 mm . Exclusion Criteria: General contraindications for implant Systemic diseases that might affect the healing of bone Patients with sinus pathology

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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No

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: sinus lift, implant placement, sole bovine bone<br>sinus floor elevation with simultaneous implant placement together with grafting the sinus with a deproteinized bovine bone solely. | Procedure: sinus lift, implant placement, sole bovine bone<br>* sinus lift augmentation with a sole deproteinized bovine bone with simultaneous implant placement<br>|
| Experimental: sinus lift, implant placement, injectable PRF + bovine bone<br>sinus floor elevation with simultaneous implant placement together with grafting the sinus with a mixture of injectable platelet rich fibrin with a deproteinized bovine bone. | Procedure: sinus lift, implant placement, injectable PRF + bovine bone<br>* sinus lift augmentation with a mixture of injectable platelet rich fibrin plus a deproteinized bovine bone with simultaneous implant placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | evaluation of postoperative complications in terms of pain and edema using patient pain chart | 7 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant stability | measurement of implant stability using osstell device | will be measured intraoperatively immediately after insertion of the implant and will be measured one more time 6 months after the first operation at time of implant exposure | 
| height of bone gained around the implant | two cone beam computed tomography (CBCT) will be taken one immediate postoperative and the other 6 months after the first operation then the height of bone gained around the implant will be assessed by superimposing the same sections in the two CBCT | 6 months postoperative | 
| bone density around the implant | Bone density will be measured by calculating the difference in the Hounsfield unit (HU) in the bone around the implants in the immediate postoperative CBCT (within one week) and the CBCT after 6 months. | 6 months postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sinus lift, injectable platelet rich fibrin, sticky bone, bovine bone