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临床试验/NCT06770231
NCT06770231已完成不适用

Peri-implant Bone Behavior After Single Drilling Technique Versus Undersized Technique of Immediately Loaded Implant in Posterior Maxilla: A One-year Prospective Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年5月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Implant stability

研究概览

简要总结

Two different drilling techniques in posterior maxilla immediate loading implant

详细描述

One of the surgical techniques used to enhance the primary stability of implant in low density bone was the undersized drilling technique, which has been introduced to locally optimize poor density of bone by using a final drill diameter considerably smaller compared with the implant diameter.

On the other hand, a novel hollow drill with a single drilling systems was designed. Single drilling technique shortens surgical times, removes the smallest amount of bone during implant site preparation, reduces bone damage and micro fractures, and speeds up the healing process. Additionally, because of the hollow shape, bone core may be harvested and used as an autogenous bone grafting material.

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
Quadruple (Participant, Care Provider, 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 with missing single or multiple teeth in posterior maxilla.
  • •Age more than 18 years.
  • •10 mm or more vertical bone height is present.
  • •Good oral hygiene.
  • •Patients willing to be present during the study follow up intervals.
  • •Patients free from any systemic diseases.
  • •6 mm or more ridge width is present.
  • •Crown height space of at least 8 mm.
  • •Patients without any para-functional habits (bruxism and clenching).

排除标准

  • •Patients with any pathological lesion or root tips at the planned surgical site.
  • •Patients with inadequate bone height and thickness.
  • •Smoking more than 14 cigarettes per day.14
  • •Alcohol or drug abuse.
  • •Patients with systemic diseases that absolutely contraindicate implant placement.

研究组 & 干预措施

Undersized technique

Experimental

New drilling tech

干预措施: Single drill system (Other)

Single drill technique

Active Comparator

One drill system

干预措施: Single drill system (Other)

结局指标

主要结局

Implant stability

时间窗: 12 months

Implant stability will be assessed at the time of implant insertion and at 3, 6 and 12 months after surgery.

Modified Sulcus Bleeding Index (mBI)

时间窗: 12 months

It will be measured at 3,6 and 12 months post-operatively. Clinical signs and symptoms of inflammation of peri-implant mucosa will be graded using criteria of modified sulcus bleeding index (mBI).

Peri-implant probing depth

时间窗: 12 months

Depth of the peri-implant sulcus will be recorded initially at the time of loading, 3, 6 and 12 months following implant loading by a graduated periodontal probe with light force to avoid undue tissue damage and over-extension into the healthy tissue

Marginal Bone Loss

时间窗: 12 months

For the calculation of marginal bone loss (MBL), the implant will be used as a reference by adjusting the cross-sectional and panoramic long axis in the center of the implant and bisecting it

Bone Density Recordings

时间窗: 12 months

Relative bone density records will be collected from the bucco-palatal view of the cross-sectional plane using the greyscale bone measuring tool

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

Mohamed Galal

Clinical demonstrator oral and maxillofacial surgery Mansoura university

Mansoura University

研究点 (1)

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