NCT03496038

Transcrestal Lateral Sinus Floor Elevation in Implant Therapy

Trans-crestal Sinus Floor Elevation in Implant Therapy: A Randomized Controlled Clinical Trail With Parallel Group Design: L-PRF Compared With DBBM

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Edentulous; Alveolar Process, Atrophy

Interventions

Type	Name	Description
PROCEDURE	L-PRF	The use of the L-PRF as graft material for sinus augmentation procedure will be analysed
PROCEDURE	DBBM	The use of bovine xenograft as graft material for sinus augmentation procedure will be analysed

Timeline

• Start date: 2018-03-19
• Primary completion: 2022-01-01
• Completion: 2022-06-01
• First posted: 2018-04-12
• Last updated: 2021-10-15

Locations

1 site across 1 country: Belgium