Lateral Sinus Floor Elevation in Implant Therapy.

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Edentulous; Alveolar Process, Atrophy

Treatments: Procedure: DBBM; Procedure: L-PRF block

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03495700

Cortellini60095

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of informed consent
• Need for L and oral implant placement.
• RBH <4mm
• RBH >4mm, but no T possible (due to anatomy)

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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24 participants in 2 patient groups

L-PRF block

Experimental group

Description:

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. Eight tubes (9 ml) of venous blood will be collected from the patients. For 6 tubes (red cap) a 12 min centrifugation at 2700 rpm/408g RCF will be followed. Two tubes (white cap) will be centrifuged (IntraSpin, Intra-Lock, Florida, USA) for 3 minutes only to form the Liquid Fibrinogen. 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). To prepare the L-PRF Block, L-PRF membranes will be cut into small pieces and mixed with DBBM (Bio-Oss Small particles, Geistlich AG, Wolhusen, Switzerland). The Liquid Fibrinogen will be added to the homogeneous mix, and stirred gently for ± 10 seconds while shaping it to the L-PRF block

Treatment:

Procedure: L-PRF block

DBBM

Active Comparator group

Description:

For the control 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). The window will be closed with a collagen membrane (Bio-Gide, Geistlich AG, Wolhusen, Switzerland).

Treatment:

Procedure: DBBM