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
1 other identifier
interventional
28
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 9, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 14, 2017
June 1, 2017
1 year
June 9, 2017
June 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patient satisfaction
evaluation of postoperative complications in terms of pain and edema using patient pain chart
7 days postoperative
Secondary Outcomes (3)
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
height of bone gained around the implant
6 months postoperative
bone density around the implant
6 months postoperative
Study Arms (2)
sinus lift, implant placement, sole bovine bone
ACTIVE COMPARATORsinus 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
EXPERIMENTALsinus floor elevation with simultaneous implant placement together with grafting the sinus with a mixture of injectable platelet rich fibrin with a deproteinized bovine bone.
Interventions
sinus lift augmentation with a sole deproteinized bovine bone with simultaneous implant placement
sinus lift augmentation with a mixture of injectable platelet rich fibrin plus a deproteinized bovine bone with simultaneous implant placement
Eligibility Criteria
You may qualify if:
- Patients requiring implants in maxilla and have atrophic bone regarding the length due to sinus pneumatiztion. Length 3: 7 mm .
You may not qualify if:
- General contraindications for implant
- Systemic diseases that might affect the healing of bone
- Patients with sinus pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 9, 2017
First Posted
June 14, 2017
Study Start
July 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
June 14, 2017
Record last verified: 2017-06