Lateral Sinus Floor Elevation in Implant Therapy.

Lateral Sinus Floor Elevation in Implant Therapy: A Randomized Controlled Clinical Trail: L-PRF Block Compared With DBBM.

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.

Study Overview

• Status: Completed
• Conditions: Edentulous; Alveolar Process, Atrophy
• Intervention / Treatment: Procedure: L-PRF block; Procedure: DBBM

Detailed 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. 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. The drilling will be performed according to implant protocol and the implant will be placed. Follow-up will be till 5 year.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Males and females ≥ 18 years of age.
• Ability to understand the nature of the proposed surgical procedure and sign an informed consent form.
• ASA I and ASA II.
• In need of an implant in the posterior region of the maxilla,
• RBH of <4 mm or RBH >4 mm but no transcrestal approach possible (due to anatomy).
• Healthy oral mucosa and no active periodontal disease.
• Edentulous sites consisting of native, non-augmented bone.

Exclusion Criteria:

• General contraindications for implant placement and/or surgical treatment.
• Acute infection or residual lesions in the edentulous sites.
• Acute maxillary sinus pathosis.
• Ongoing inflammatory and/or autoimmune diseases of the oral cavity.
• Patients with poor oral hygiene who are not amenable to improvement.
• Immunosuppressants, corticosteroids, or bisphosphonate
• History of malignancy, radiotherapy, or chemotherapy for malignancy within the past five years.
• Smoker > 10 cigarettes.
• Uncontrolled insulin-dependent diabetes.
• Pregnant or lactating women.
• Alcohol and drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-PRF block; 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	Procedure: L-PRF block; The use of the L-PRF block as graft material for sinus augmentation procedure will be analysed
Active Comparator: DBBM; 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).	Procedure: DBBM; The use of bovine xenograft will be analysed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volumetric bone regeneration	Amount of bone formation after lateral sinus floor elevation scored at implant placement, measured on CBCT images. Following a healing period of 6 months a CBCT will be taken to evaluate the height and width of the newly formed bone and compare it to the initial CBCT. A 3-D volumetric analysis of the amount of gained bone is conducted with MeVisLab software.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival	The implants inserted after sinus grafting procedures would be followed for up to 5 years. Marginal bone loss would be examined using intraoral long-cone radiographs	5 years
Linear bone regeneration	Amount of bone formation after lateral sinus floor elevation scored at implant placement, measured on CBCT images. Following a healing period of 6 months a CBCT will be taken to evaluate the height and width of the newly formed bone and compare it to the initial CBCT. 2-D measurements will be performed.	6 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Dentsply International

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): June 6, 2024

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Tooth Diseases; Pathological Conditions, Signs and Symptoms; Atrophy; Mouth, Edentulous
• Other Study ID Numbers: Cortellini60095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes