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

Not Applicable

• Conditions: Sinus Floor Elevation
• Interventions: Procedure: sinus lift, implant placement, sole bovine bone; Procedure: sinus lift, implant placement, injectable PRF + bovine bone

• Registration Number: NCT03184831
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-07
• Status Verified: 2017-06
• Study First Submitted: 2017-06-09
• Study First Submitted QC: 2017-06-09
• Last Update Submitted: 2017-06-09
• Study First Posted: 2017-06-14
• Last Update Posted: 2017-06-14
• Primary Completion: 2017-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Patients requiring implants in maxilla and have atrophic bone regarding the length due to sinus pneumatiztion. Length 3: 7 mm .

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Exclusion Criteria

1. General contraindications for implant
2. Systemic diseases that might affect the healing of bone
3. Patients with sinus pathology

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sinus lift, implant placement, sole bovine bone	sinus lift, implant placement, sole bovine bone	sinus floor elevation with simultaneous implant placement together with grafting the sinus with a deproteinized bovine bone solely.
sinus lift, implant placement, injectable PRF + bovine bone	sinus lift, implant placement, injectable PRF + bovine bone	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.

Primary Outcome Measures

Name	Time	Method
patient satisfaction	7 days postoperative	evaluation of postoperative complications in terms of pain and edema using patient pain chart

Secondary Outcome Measures

Name	Time	Method
implant stability	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	measurement of implant stability using osstell device
height of bone gained around the implant	6 months postoperative	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
bone density around the implant	6 months postoperative	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.