Lateral Sinus Floor Elevation in Implant Therapy.

NCT03495700 | Completed DMC

• 1 other identifier: Cortellini60095
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulous; Alveolar Process, Atrophy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Implant survival

  5 years

• Linear bone regeneration

  6 months

Study Arms (2)

L-PRF block

EXPERIMENTAL

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

DBBM

ACTIVE COMPARATOR

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

Interventions

L-PRF block PROCEDURE

The use of the L-PRF block as graft material for sinus augmentation procedure will be analysed

L-PRF block

DBBM PROCEDURE

The use of bovine xenograft will be analysed

DBBM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Mouth, Edentulous; Atrophy

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical and Research Associate

Model Details: This study is designed as a randomized controlled clinical trial.

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 12, 2018
• Study Start: March 19, 2018
• Primary Completion: February 14, 2019
• Study Completion: June 6, 2024
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

BE (1)