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临床试验/NCT02926781
NCT02926781Unknown不适用

A Comparative Study to Evaluate Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Specially Designed Drills Versus the Conventional Osteotome Technique: a Randomized Controlled Clinical Trial.

Cairo University0 个研究点目标入组 18 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
18
主要终点
bone height gain

研究概览

简要总结

Radiographic evaluation of the amount of bone height gain and clinical evaluation of the possibility of developing complications after transcrestal sinus floor elevation using drills and the conventional osteotome technique.

详细描述

Short implants (< 10 mm) are one of the options used to overcome low vertical bone height in the maxilla. However, short implants have faced many challenges as smaller implant surface; therefore less bone-to-implant contact after osseointegration with force distribution on a reduced surface after loading. This leads to more crestal bone resorption with more threads exposure decreasing the long term implant success Another treatment option is placing implants in specific anatomical areas, such as the pterygoid region or the zygoma .Many complications are reported as postoperative sinusitis, temporary paresthesia, epistaxis, facial, periorbital hematoma, orbital penetration and prosthetic difficulties due to the implants palatal emergence.

Vertical augmentation with bone grafts is another treatment option. However, it has many drawbacks as the unpredictable graft resorption, low bone to implant contact, higher possibility of wound dehiscence, as well as compromised implant position leading to undesirable prosthetic restorations.

To overcome the problems of the previously mentioned procedures, elevation of the sinus membrane techniques were proposed, it can be performed either through a lateral window , or via a crestal access depending on the remaining bone height (RBH). If the RBH is around 6-9 mm, the crestal approach is indicated. If the RBH is less than 5 mm, a lateral approach should be performed.

For the crestal approach, it could be performed by the conventional osteotome technique. However, it is a visually restrictive technique which may lead to sinus perforation as well as it can cause some complications as headache and paroxysmal positional vertigo (Saker e Ogle, 2005; Peñarrocha-Diago et al., 2008).

To overcome the disadvantages of the conventional osteotome technique, various kits have been developed for transcrestal sinus floor elevations using specially designed drills.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients having at least one missing upper posterior tooth.
  • •Residual bone height beneath maxillary sinus from 5-8 mm .
  • •A minimum of 6 mm residual bone width.
  • •The recipient site of the implant should be free from any pathological condition.
  • •No diagnosed bone disease or medication known to affect bone metabolism.
  • •Patients who are cooperative, motivated and hygiene conscious.
  • •Patients having proper inter-occlusal space.

排除标准

  • •Systemic conditions/disease that contraindicated surgery.
  • •Radiation therapy in the head and neck region or chemotherapy during the 12 months prior to surgery.
  • •Patients who have any habits that might jeopardize the osseointegration process, such as current smokers.
  • •Patients with parafunctional habits that produce overload on implant, such as bruxism and clenching.
  • •Patients that have any pathology in the maxillary sinuses.

研究组 & 干预措施

drills

Active Comparator

transcrestal sinus floor elevation using drills

干预措施: Dask Advanced Sinus kit (Device)

osteotome technique

Experimental

transcrestal sinus floor elevation using osteotomes

干预措施: Dask Advanced Sinus kit (Device)

结局指标

主要结局

bone height gain

时间窗: 6 months

次要结局

未报告次要终点

研究者

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

Omar Ashour

Resident

Cairo University

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