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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-22

Study Completion Date

2024-04-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study compared two groups: one receiving DBBM alone (control) and the other receiving a combination of DBBM and an L-PRF block (test group).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control Group

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

Group Type ACTIVE_COMPARATOR

Sinus lift augmentation with bone substitute (Bio-Oss)

Intervention Type PROCEDURE

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.

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))

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes