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.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement
- Sponsor
- University of Santiago de Compostela
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Percentage of new bone formed
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Juan Blanco Carrión
PhD
University of Santiago de Compostela
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- 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)