Efficacy of L-PRF Against Deproteinized Bovine Mineralized Bone (DBBM)

University of Santiago de Compostela

Status and phase: Completed; Phase 4

Conditions: Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement

Treatments: Procedure: Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF Block; Procedure: Sinus lift augmentation with bone substitute (Bio-Oss)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06686836

2021-005374-26 (EudraCT Number)

ECAELEV21

Details and patient eligibility

About

Objective: The main objective of this study is to evaluate whether the use of L-PRF combined with deproteinized bovine mineralized bone (DBBM; BioOss, Geistlich Pharma®) reduces healing time, through histomorphometric analysis using bone biopsies after maxillary sinus elevation versus the use of deproteinized bovine mineralized bone (DBBM) alone.

Materials and methods: 24 patients with posterior maxillary atrophy (residual bone height <5mm without need for vertical regeneration) and need for sinus lift surgery to allow implant placement were treated ,12 DBBM (control group) 12 L-PRF block (Test group). At 4 months after sinus lift, a biopsy was taken and implants were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically. Patients received prosthetic restorations after 9 months and were followed up at 12 months. Volumetric changes were analyzed at 4 and 12 months.

Full description

The study was a double-blind randomized controlled clinical trial (RCT), with a parallel design. Patients requiring an open sinus lift procedure before implant placement.

For the procedure it was use two types of filler, L-PRF block (test group) and DBBM alone (control group).

All patients were randomized and assigned to each of the study groups through a computer-generated randomization.

The primary outcome was percentage of new bone formed after treatment by histological and histomorphometric measurement of biopsies (%NeoformedBone=(Regenerated bone/total area)x100) at 4 and 6 months.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients >18 years
• Presence of oral health (periodontally healthy or periodontitis treated), with a BoP <20% and PI <20%.
• Systemically healthy, with no disease that might contraindicate oral surgery.
• Non-smokers or smokers of <10 cig/day.
• Need to place implants in postero-superior sector with a residual bone height of < 5mm (no need for vertical regeneration).
• More than 3 months since tooth extraction in the treatment area.
• Absence of sinus pathology.

Exclusion criteria

• Patients who, due to systemic conditions, blood extraction is not possible.
• Medication that may interfere with bone metabolism (e.g. corticosteroids, bisphosphonates).
• History of radiotherapy.
• Pregnant and/or breastfeeding women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Control Group

Active Comparator group

Description:

Open sinus lift surgery using a bone substitute Bio-Oss®(Geistlich AG, Wolhusen, Switzerland) alone.

Treatment:

Procedure: Sinus lift augmentation with bone substitute (Bio-Oss)

Test Group

Experimental group

Description:

Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland))

Treatment:

Procedure: Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland)) - L-PRF Block