Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03495700 |
Other study ID # |
Cortellini60095 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 19, 2018 |
Est. completion date |
June 2022 |
Study information
Verified date |
October 2021 |
Source |
Universitaire Ziekenhuizen Leuven |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The L-PRF block is a combination of bone substitute with L-PRF. The use of a L-PRF block in
bone augmentation therapies could enhance and improve bone regeneration.
The primary objective of this study is to evaluate if the use of autologous leukocytes and
platelet rich fibrin accelerate and promotes bone regeneration in the sinus in comparison
with the standard sinus lift procedure procedure.
Description:
This is a randomized controlled clinical trial. A total of 24 patients, needing sinus lift
with lateral window technique (L), will be enrolled. All patients have to fulfil all of the
inclusion and none of the exclusion criteria. The trial will comprise 8 visits. Written
informed consent will be obtained prior to any examination carried out for study purposes.
Randomization will be performed using sealed, sequentially numbered, opaque envelopes
containing treatment allocation.
Under local anaesthesia, the required L will be performed. Once the blood extraction is done
the surgery can start following the normal procedure for the lateral approach of sinus floor
elevation. Once the preparation of the sinus floor elevation is done the randomization
envelopes will be open and the selected treatment will be applied. For the test group the
sub-sinus cavity will be filled with L-PRF block and the window will be closed with L-PRF
membranes. For the control group the sub-sinus cavity will be filled with only DBBM and the
window will be closed with a collagen membrane. Afterwards suturing will be conducted and a
CBCT will be taken for control and observation.
After 6 months the subjects return for a check-up of the healing process. A CBCT will be
taken to assess the bone regeneration. Implant surgery will be discussed.
With a crestal incision the implant site will be exposed. A trephine bur of 3 mm in diameter
will be use to obtain a biopsy of the test or control site. This will result in a biopsy
sample of the healed site. At the exact same location of the biopsy the drilling will be
performed according to implant protocol and the implant will be placed and ISQ values will be
recorded. Follow-up will be till 1 year.