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.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Percentage of new bone formed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control Group
Open sinus lift surgery using a bone substitute Bio-Oss®(Geistlich AG, Wolhusen, Switzerland) alone.
干预措施: Sinus lift augmentation with bone substitute (Bio-Oss) (Procedure)
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))
干预措施: 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)
结局指标
主要结局
Percentage of new bone formed
时间窗: 4 and 6 months after treatment
Measured by histological and histomorphometric analysis of biopsies at 4 and 6 months after sinus lift surgery
次要结局
- 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)
研究者
Juan Blanco Carrión
PhD
University of Santiago de Compostela