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LPRF Block vs. DBBM in Horizontal Bone Reconstruction

2026年5月7日 更新者:Ana CASTRO SARDA、Universitaire Ziekenhuizen KU Leuven

Horizontal Guided Bone Regeneration: LPRF Block vs. a Mixture of Autogenous Bone With Deproteinized Bovine Bone Mineral. A Split-mouth RCT Study With 25 Months Follow-up

split-mouth RCT. 12 patients. horizontal GBR performed. 2 grafts were compared: test was LPRF block, control was 50% autogenous bone and 50% DBBM. 25 months follow-up.

研究概览

地位

完全的

详细说明

12 patients were included in this split-mouth RCT. In test sites a horizontal GBR procedure was performed using a collagen membrane with a graft consisting of 50% autogenous bone and 50% DBBM. In control sites a collagen membrane was used, with a graft consisting of an LPRF block. This was left to heal for 9 months. Subsequently an implant was placed. At time of implant placement a bone biopsy was taken. After 4 months of osseointegration the abutment connection was performed. 1 year after loading of the implants a final check was done. CBCT scans were taken at intake, immediately after reconstruction, 9 months after reconstruction, before implant placement and 1 year after loading of the implants.

Primary outcome measure is the bone volume as measured on the CBCT scans. Secondary outcome measures are bone quality in the biopsy, buccal bone thickness around the oral implant, number and type of complications, cumulative survival rates of the implants 1 year after loading.

研究类型

介入性

注册 (实际的)

12

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Vlaams-Brabant
      • Leuven、Vlaams-Brabant、比利时、3000
        • UZ Leuven

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Males or females, with ASA I or II, between 18 and 80 years old
  • 2 implant sites requiring vertical bone augmentation prior to implant placement
  • Both sites in the same jaw
  • Good general health as documented by self-assessment

Exclusion Criteria:

  • Any systemic medical condition that could interfere with the surgical procedure, planned treatment or healing of the patient
  • Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
  • Current pregnancy or breast feeding/ lactating at the time of recruitment.
  • Radiotherapy or Chemotherapy in head and neck area.
  • Intravenous and oral bisphosphonate therapy.
  • Smoking
  • Unwillingness to return for the follow-up examination.
  • Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations
  • Presence of osseous pathologies, that might interfere with normal wound healing
  • Presence of oral lesions (such as ulceration, malignancy)
  • Local inflammation, including untreated periodontitis
  • Patients with inadequate oral hygiene or unmotivated for adequate home care

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:LPRF block group
LPRF block covered by collagen membrane
Bone grafting procedure using a particulated bone graft, covered by a resorbable membrane
其他名称:
  • 英国
  • Implant placement after bone healing
实验性的:Compound graft group
50% autogenous bone with 50% DBBM covered by collagen membrane.
Bone grafting procedure using a particulated bone graft, covered by a resorbable membrane
其他名称:
  • 英国
  • Implant placement after bone healing

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
bone volume changes
大体时间:at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative
bone volume is measured on CBCT scans of the jaw
at intake, immediately after surgery, 9 months postoperative, 13 months postoperative, 25 months postoperative

次要结果测量

结果测量
措施说明
大体时间
buccal bone thickness on CBCT scan
大体时间:measured at placement of the implant and 1 year later
thickness of the buccal bone plate of the oral implant
measured at placement of the implant and 1 year later
Cumulative survival rate of the implants
大体时间:measured at the 1 year loading follow-up
survival of the implants over the follow-up time
measured at the 1 year loading follow-up
Rates of complications
大体时间:from the gbr surgery to 25 months follow-up
all possible complications were registered and monitored
from the gbr surgery to 25 months follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年7月2日

初级完成 (实际的)

2023年3月1日

研究完成 (实际的)

2023年3月1日

研究注册日期

首次提交

2023年6月6日

首先提交符合 QC 标准的

2026年5月7日

首次发布 (实际的)

2026年5月13日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月7日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • S59813-1

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

all info available on request

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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