Transcrestal Lateral Sinus Floor Elevation in Implant Therapy

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Edentulous; Alveolar Process, Atrophy

Treatments: Procedure: DBBM; Procedure: L-PRF

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03496038

Cortellini60096

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of informed consent
• Need for T and oral implant placement.
• RBH >3mm

Exclusion criteria

• Unlikely to be able to comply with the study procedures, as judged by the investigator
• Untreated periodontal disease
• Unfavorable plaque control
• Known or suspected current malignancy
• History of chemotherapy within 5y prior to study
• History of radiation on the head and neck region
• History of other metabolic bone diseases
• Need for systemic corticosteroids
• Current or previous use of intravenous/oral bisphosphonates
• Present alcohol and/or drug abuse
• Involvement in the planning and conduct of the study
• Psychiatric disorders which do not allow a normal treatment outcome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Leukocyte and Platelet Rich Fibrin (L-PRF)

Experimental group

Description:

For the test group the sub-sinus cavity will be filled with Leukocyte en Platelet Rich Fibrin (L-PRF). Before starting the surgery, 8 tubes (9 ml) of venous blood will be collected from the patients. A centrifugation standard L-PRF protocol will be followed followed (12 minutes centrifugation, 2700 rpm/408g RCF). After full centrifugation of the tubes, the L-PRF clots will be removed from the tubes using surgical tweezers. The clots will be thereafter gently compressed into membranes using a sterile metal box (Xpression, Intra-Lock, Florida, USA).

Treatment:

Procedure: L-PRF

Deproteinized Bovine Bone Mineral (DBBM)

Active Comparator group

Description:

For the test group the sub-sinus cavity will be filled with deproteinized bovine bone mineral (DBBM). The product used will be a xenograft (Bio-Oss Small particles, Geistlich AG, Wolhusen, Switzerland).

Treatment:

Procedure: DBBM