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NCT number NCT03495700
Study type Interventional
Source Universitaire Ziekenhuizen Leuven
Contact
Status Recruiting
Phase N/A
Start date March 19, 2018
Completion date September 2019

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.


Clinical Trial 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.


Study Design


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