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临床试验/NCT07635472
NCT07635472已完成不适用

Three-dimensional Volumetric Evaluation of Deproteinized Bovine Bone Mineral Graft Dimensional Changes After Lateral Window Sinus Floor Elevation: a Long-term Retrospective Study up to 12 Years.

Saint-Joseph University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This study aims to evaluate graft volumetric changes and stability up to 12 years after lateral sinus floor elevation with deproteinized bovine bone mineral (DBBM) as a filling material.

详细描述

This study aims to assess graft volume changes and stability up to 12 years after lateral sinus floor elevation using natural bovine bone. The research will involve patients who underwent external sinus lifts starting 2011 and had pre-operative and post-operative CBCT scans. The study will include a retrospective comparison of graft volume changes using three time points: T0 (pre-operative CBCT, showing residual bone height), T1 (post-operative CBCT acquired at different time points, including immediately after the procedure T' and 9-months post-operative scans T''), and T2 (long-term post-operative CBCT). The residual bone height from T0 will be excluded in subsequent scans to focus on evaluating changes in graft volume.

For the primary outcome evaluate radiographically in 3D using CBCT volumetric changes in region of lateral sinus lift using deproteinized bovine bone graft material.

For the secondary outcome is to evaluate potential differences in graft volumetric changes among different age groups, genders, smoking vs. non-smoking patients and to evaluate implant survival. In addition to that, to detect a potential pattern in graft resorption/ stabilization for only 11 patients from Ghosn et al's study (with immediate post-operative CBCT and 9 months post-operative CBCT).

For this, a minimum sample size of 52 patients (increasing the sample size as much as possible > 60 for more accurate results) are needed for statistical analysis to detect a significant difference in graft volume and an additional 11 patients are needed from Ghosn's et al study for an additional analysis (exploratory purpose).

Patient's inclusion criteria include:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who underwent lateral sinus floor elevation with natural bovine bone as filling material after 2011 at the Faculty of Dentistry, Saint Joseph University of Beirut.
  • At least 18 years old at baseline
  • Systemically healthy
  • Patients who sign a new informed consent.
  • Smokers (≥ 10 cigarettes/ day) and non-smokers (< 10 cigarettes/ day)

排除标准

  • Patients who did not take a CBCT within 1 year after the initial surgery.
  • Presence of inflammatory lesions at the surgical site (eg, sinusitis as assessed by CBCT).
  • History of radiation therapy in the head/neck region.
  • Use of bisphosphonates.

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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