跳至主要内容
临床试验/NCT05284461
NCT05284461已完成不适用

Effect of Shape and Surface Treatment of the Transmucosal Abutments on the Bone-implant-contact and the Peri-implant Health, .

University of Salamanca2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Density of the peri-implant soft tissues

研究概览

简要总结

The sample was comprised by 10 patients in which 40 dental implants are placed in an atrophic maxilla. All the implants were connected to 4 types of transepithelial abutment: i.e: parallel anodized abutment(n=10); parallel mechanized abutmen(n=10)t, convergent anodized abutment(n=10); and convergent mechanized abutment (n=10) three months after insertion implants were extracted with the surrounding hard and soft tissues for the histological evaluation of the clinical performance.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • totally edentulous patients in the upper arch and carriers of conventional complete dentures for more than ten years, without temporomandibular disorders

排除标准

  • evidence of systemic or psychic pathology that contraindicates implant treatment.

结局指标

主要结局

Density of the peri-implant soft tissues

时间窗: 3 months after healing

Histological assessments as ordinal variables of the density of the collagen fibers (low, medium, high) according to standard guidelines.

Bone to implant contact

时间窗: 3 months after healing

It is a Percentage estimation of native bone in direct contact to implant determined by histological assessments (optical microscopy)

Peri-implant inflammation of the soft tissues

时间窗: 3 months after healing

Histological assessments as ordinal variables of the grade of inflammatory infiltrate (none, minor, major)according to standard guidelines.

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

JAVIER MONTERO

Professor in Prosthodontics

University of Salamanca

研究点 (2)

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