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

NCT06686836 | Completed Phase 4 DMC

• 2 other identifiers: ECAELEV212021-005374-26
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Posterior maxillary atrophy; Dental implants; Sinus lift; Bone grafting; Platelet-rich fibrin; Alveolar ridge augmentation; Bone regeneration; Bone substitutes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of remaining material (%)

  4 and 6 months after treatment

• Volumetric changes of regenerated bone

  baseline, 4 and 12 months after treatment

• Implant stability

  4 and 6 months after treatment

• Implant success

  12 months after treatment

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

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

Test Group

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))

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

Interventions

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.

Control 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)) - 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.

Test Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Straumanngroup: collaborator
• Geistlich Pharma AG: collaborator

Study Sites (1)

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

Santiago de Compostela, 15782, Spain

Location

Related Links

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MeSH Terms

Interventions

Bone Substitutes; Bio-Oss

Intervention Hierarchy (Ancestors)

Biocompatible Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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).

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: June 22, 2022
• Primary Completion: September 15, 2023
• Study Completion: April 17, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)