Sinus Floor ElevationNCT03184831
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
A study testing sinus lift, implant placement, sole bovine bone and sinus lift, implant placement, injectable PRF + bovine bone in people with Sinus Floor Elevation, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sinus Floor Elevation
- What is being tested?
- sinus lift, implant placement, sole bovine bone and sinus lift, implant placement, injectable PRF + bovine bone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring implants in maxilla and have atrophic bone regarding the length due to sinus pneumatiztion. Length 3: 7 mm .
Who cannot join
- General contraindications for implant
- Systemic diseases that might affect the healing of bone
- Patients with sinus pathology
About this study
Official title: 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.
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.
- Conditions
- Sinus Floor Elevation
- Being tested
- sinus lift, implant placement, sole bovine bone, sinus lift, implant placement, injectable PRF + bovine bone
- Keywords
- sinus lift, injectable platelet rich fibrin, sticky bone, bovine bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinus lift, implant placement, sole bovine boneProcedure or surgery
sinus lift augmentation with a sole deproteinized bovine bone with simultaneous implant placement
sinus lift, implant placement, injectable PRF + bovine boneProcedure or surgery
sinus lift augmentation with a mixture of injectable platelet rich fibrin plus a deproteinized bovine bone with simultaneous implant placement
| Study group | Role | What they receive |
|---|---|---|
| sinus lift, implant placement, sole bovine bone | Active comparator | sinus floor elevation with simultaneous implant placement together with grafting the sinus with a deproteinized bovine bone solely. Receives: Procedure: sinus lift, implant placement, sole bovine bone |
| sinus lift, implant placement, injectable PRF + bovine bone | Experimental | 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. Receives: Procedure: sinus lift, implant placement, injectable PRF + bovine bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
evaluation of postoperative complications in terms of pain and edema using patient pain chart
Measured: 7 days postoperative
Secondary outcomes (3)
implant stability
measurement of implant stability using osstell device
Measured: 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
Measured: 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.
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Floor ElevationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ali El Sayed Attia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184831
- Sponsor's protocol ID
- Cebc.CairoUniver
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03184831
- Acronym / sponsor ID
- Cebc.CairoUniver
- Conditions
- Sinus Floor Elevation
- Keywords
- sinus lift, injectable platelet rich fibrin, sticky bone, bovine bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sinus lift, implant placement, sole bovine bone | Active comparator | Procedure: sinus lift, implant placement, sole bovine bonesinus 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 | Experimental | Procedure: sinus lift, implant placement, injectable PRF + bovine bonesinus floor elevation with simultaneous implant placement together with grafting the sinus with a mixture of injectable platelet rich fibrin with a deproteinized bovine bone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring implants in maxilla and have atrophic bone regarding the length due to sinus pneumatiztion. Length 3: 7 mm .
Key exclusion criteria (3 listed)
- General contraindications for implant
- Systemic diseases that might affect the healing of bone
- Patients with sinus pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sinus lift, implant placement, sole bovine bonesinus lift augmentation with a sole deproteinized bovine bone with simultaneous implant placement | Procedure or surgery | sinus lift, implant placement, sole bovine bone |
| sinus lift, implant placement, injectable PRF + bovine bonesinus lift augmentation with a mixture of injectable platelet rich fibrin plus a deproteinized bovine bone with simultaneous implant placement | Procedure or surgery | sinus lift, implant placement, injectable PRF + bovine bone |
Primary outcome
patient satisfaction
Time frame: 7 days postoperative
evaluation of postoperative complications in terms of pain and edema using patient pain chart
3 secondary outcomes
implant stability
Time frame: 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
Time frame: 6 months postoperative
bone density around the implant
Time frame: 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sinus lift, implant placement, sole bovine bone and sinus lift, implant placement, injectable PRF + bovine bone in people with Sinus Floor Elevation, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: 7 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.