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Clinical Trial Summary

This is a non-inferiority study to evaluate whether L-PRF achieves similar or perhaps better results in bone gain, compared with "the golden standard" DBBM, after trans-crestal sinus floor elevation.

Clinical Trial Description

This is a randomized controlled clinical trial with parallel group design. A total of 40 patients, needing transcrestal sinus lift (T), will be enrolled.

Under local anesthesia, the required T and implant placement will be performed and ISQ values will be recorded. Afterwards a CBCT will be taken for control. Randomization will be performed by computer generated random codes, using random permuted blocks with a block size of 4 to avoid uneven splits and minimization for the key prognostic factors RBH. Allocation will be concealed to the surgeons at completion of the common part of treatment, by opening an opaque envelope. At the same time an oral implant(s) will be inserted in the augmented area.

After 6 months a CBCT will be taken for control of the bone healing and the measurements of the newly formed bone. The abutment will be placed on top of the osseo-integrated implant(s) under local anesthesia. ISQ values will be recorded. Follow-up will be till 1 year. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03496038
Study type Interventional
Source Universitaire Ziekenhuizen Leuven
Status Recruiting
Phase N/A
Start date March 19, 2018
Completion date September 2019

See also
  Status Clinical Trial Phase
Completed NCT03401554 - Titanium Mesh Versus Collagen Membrane for Closure of Window in Maxillary Sinus Elevation With Implant Placement N/A
Recruiting NCT03495700 - Lateral Sinus Floor Elevation in Implant Therapy. N/A