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

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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03184831

Enrollment

Registered

2017-06-14

Start date

2016-07-31

Completion date

2017-07-31

Last updated

2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus Floor Elevation

Keywords

sinus lift, injectable platelet rich fibrin, sticky bone, bovine bone

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.

Interventions

PROCEDUREsinus lift, implant placement, sole bovine bone

sinus lift augmentation with a sole deproteinized bovine bone with simultaneous implant placement

PROCEDUREsinus lift, implant placement, injectable PRF + bovine bone

sinus lift augmentation with a mixture of injectable platelet rich fibrin plus a deproteinized bovine bone with simultaneous implant placement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
patient satisfaction	7 days postoperative	evaluation of postoperative complications in terms of pain and edema using patient pain chart

Secondary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026