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Completed

NCT Number: NCT06686836

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of periodontology, Faculty of Dentistry, University of Santiago de Compostela

Santiago de Compostela, 15782, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sinus lift augmentation with bone substitute (Bio-Oss)

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.

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

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.

Primary outcomes

  1. Percentage of new bone formed

    Time frame: 4 and 6 months after treatment

    Measured by histological and histomorphometric analysis of biopsies at 4 and 6 months after sinus lift surgery

Secondary outcomes

  1. Percentage of remaining material (%)

    Time frame: 4 and 6 months after treatment

    Measured by histology analysis at 4 and 6 months;

  2. Volumetric changes of regenerated bone

    Time frame: baseline, 4 and 12 months after treatment

    Measured in millimeters according to CBCT at 4 and 12 months after maxillary sinus lift in apico-coronal and bucco-lingual orientation

  3. Implant stability

    Time frame: 4 and 6 months after treatment

    Mesured ISQ (>65N) at the time of implant placement and in the second surgical phase before connecting the abutment to the implant).

  4. Implant success

    Time frame: 12 months after treatment

    According to the criteria described by Misch,2008

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Collaborators

  • Geistlich Pharma AG
  • Straumanngroup

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 13, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.