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临床试验/NCT07348094
NCT07348094招募中不适用

Computer-Guided Lateral Sinus Floor Elevation Using Autologous Serum Albumin/Platelet Rich Fibrin Combined With Serum Albumin Membrane: A Randomized Clinical Study

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年1月26日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
Implant stability

研究概览

简要总结

This research aimed to evaluate the effect of an autologous Alb-PRF on bone regeneration after lateral sinus lifting via 3D volumetric analysis. The null hypothesis of this research was that there would be no significant difference between the group that would be treated by lateral sinus lift and Alb-PRF application and that would be treated by lateral sinus lift with bone graft for bone regeneration.

详细描述

Sinus floor augmentation became a widely accepted surgical procedure to improve the amount of bone volume before implant placement. According to the guided bone regeneration principles, in the sinus lift procedure, bone graft was demonstrated to act as space holder under the elevated sinus membrane. The osteogenic source for the bone healing derives from two different anatomic sites: the basal bone of the sinus cavity and the periosteum represented as basal cell layer of the Schneiderian membrane.

Proper and accurate design and location of the lateral side window is necessary to facilitate the sinus lifting process and help the surgeon to successfully lift the sinus membrane. In addition, direct visualization helps in better packing of the entire graft space, which is essential to provide primary stability for the simultaneous insertion of the implants with the sinus elevation procedure.

The application of digital technology has proven to be a valuable tool for diagnosis and treatment planning. Data obtained from CBCT scans, digital oral scans, and facial scans can be integrated and manipulated using special computer software, providing surgeons with an interactive interface to perform virtual surgery planning before the actual surgery.

The precision of stereolithographic guides may mitigate risks associated with anatomical variations in atrophic maxillae, potentially reducing membrane perforation and optimizing lateral window osteotomy and implant placement accuracy which are key factors this study evaluates.

Recently, the use of pure autologous concentrations of platelets, PRF, as a graft material has shown promising effects. However, the durability of PRF is limited, as it usually resorbs within 10-14 days. Thus, Mourão et al. introduced a new technique for PRF preparation, in which the resulting newly formed protein remains stable for a long time, up to 4 to 6 months. The buffy coat layer of the PRF was then mixed with the denatured albumin gel and cooled to room temperature to form a new autologous albumin gel-platelet-rich fibrin mixture (Alb-PRF) which has the ability to heal, represented by the delayed and gradual release of growth factors present in the buffy coat layer of PRF throughout the prolonged dissolution of the albumin gel.

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
Single (Outcomes Assessor)

盲法说明

outcome assessor is masked

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females ≥18 years of age.
  • ASA I and ASA II.
  • Patients having partial edentulism in the posterior region of the maxilla.
  • Edentulous sites consist of native non augmented bone.
  • Horizontal ridge dimension minimum of 5mm
  • The vertical ridge dimension 3-6 mm.
  • Bone quality of D2 or D
  • Enough inter-arch distance.

排除标准

  • - Patients with uncontrolled systemic diseases.
  • History of chronic maxillary sinus pathology.
  • Heavy smokers or patients with poor oral hygiene.

研究组 & 干预措施

Group II

Experimental

Lateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then an autologous Alb-PRF only will be used

干预措施: Guided Lateral Sinus Lifting with Autologous Serum Albumin/Platelet-Rich Fibrin (Procedure)

Group III

Experimental

Lateral window was done using surgical guide for placement of fifteen implants in posterior edentulous maxillary regions. Then sticky bone [bone graft with Alb-PRF] only will be used

干预措施: Guided Lateral Sinus Lifting with sticky bone (Procedure)

Group I

Experimental

Lateral window was done using surgical guide for placement of implants in posterior edentulous maxillary regions. Then bone graft only will be used.

干预措施: Guided Lateral Sinus Lifting with bone graft (Procedure)

结局指标

主要结局

Implant stability

时间窗: 12-months

using implant stability quotient device

次要结局

  • Vertical bone height gain(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walid Elamrousy

Professor of Periodontology Department Faculty of Oral and Dental Medicine,Kafrelsheikh University

Kafrelsheikh University

研究点 (1)

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