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

Efficacy of Platelet- and Leukocyte-rich Fibrin (L-PRF) in Reducing Healing Time in Sinus Lift Combined with Deproteinized Bovine Mineralized Bone (DBBM): Randomized Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement
• Intervention / Treatment: Procedure: Sinus lift augmentation with bone substitute (Bio-Oss); 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

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Santiago de Compostela, Spain, 15782
    • Department of periodontology, Faculty of Dentistry, University of Santiago de Compostela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

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
Active Comparator: Control Group; Open sinus lift surgery using a bone substitute Bio-Oss®(Geistlich AG, Wolhusen, Switzerland) alone.	Procedure: Sinus lift augmentation with bone substitute (Bio-Oss); A maxillary sinus lift augmentation was performed with a lateral window approach that was filled with a bone substitute (Bio-Oss®) and covered with a collagen membrane (Bio-Guide®).At 4 months after sinus lift, a biopsy was taken and implants (Starumann®) 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.
Experimental: Test Group; Open sinus lift surgery lift using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®(Geistlich AG, Wolhusen, Switzerland))	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; A maxillary sinus lift augmentation was performed with a lateral window approach that was filled using Platelet- and leukocyte-rich fibrin (L-PRF) mixed with a bone substitute (Bio-Oss®) and covered with a collagen membrane (Bio-Guide®) (L-PRF block). L-PRF block will be performed as described by Cortellini et al. 2018. L-PRF membranes are cut into small pieces and mixed with Bio-Oss® at a ratio of 2 membranes / 0.5 g biomaterial. Pieces of the block will be removed and compacted in the sinus cavity until it is filled. At 4 months after sinus lift, a biopsy was taken and implants (Starumann®) 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of new bone formed	Measured by histological and histomorphometric analysis of biopsies at 4 and 6 months after sinus lift surgery	4 and 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of remaining material (%)	Measured by histology analysis at 4 and 6 months;	4 and 6 months after treatment
Volumetric changes of regenerated bone	Measured in millimeters according to CBCT at 4 and 12 months after maxillary sinus lift in apico-coronal and bucco-lingual orientation	baseline, 4 and 12 months after treatment
Implant stability	Mesured ISQ (>65N) at the time of implant placement and in the second surgical phase before connecting the abutment to the implant).	4 and 6 months after treatment
Implant success	According to the criteria described by Misch,2008	12 months after treatment

Collaborators and Investigators

• Sponsor: University of Santiago de Compostela
• Collaborators: Geistlich Pharma AG; Straumanngroup

Publications and helpful links

Helpful Links

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Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): April 17, 2024

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Estimated): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Posterior maxillary atrophy; Dental implants; Sinus lift; Bone grafting; Platelet-rich fibrin; Alveolar ridge augmentation; Bone regeneration; Bone substitutes
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: ECAELEV21; 2021-005374-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No