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临床试验/NCT06620497
NCT06620497已完成不适用

Marginal Bone Loss, Prosthetic and Mucosal Complications of Stress-free Implant Bars and Milled Bars Supporting Mandibular Overdentures. Three-years Randomized Clinical Trial

Fayoum University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年6月6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
8
试验地点
1
主要终点
marginal bone loss

研究概览

简要总结

The aim of this study will be to evaluate the marginal bone loss and prosthetic complications of stress-free implant (SFI) and milled bars used to assist mandibular 4-implant overdentures after 3 years

详细描述

Eight edentulous participants with insufficient stability of mandibular dentures will receive 4 implants in the mandibular ridge (2 implants in the canine areas and 2 implants in the first molar areas), and then after 3 months, patients will be randomly assigned into 2 groups; 1) group 1: will include 4 participants who will receive milled bar overdentures, and 2) group 2: will include 4 participants who will receive SFI bar overdentures. For both groups, marginal bone loss will be evaluated using the standardized digital periapical films at the time of insertion, 6 months, 1 year, and 3 years after insertion. Prosthetic and mucosal complications will be evaluated after 3 years.

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)

入排标准

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

入选标准

  • •mandibular edentulous ridge

排除标准

  • •severe atrophy in mandibular ridge

研究组 & 干预措施

SFI group

Experimental

干预措施: stress free implant bar (Procedure)

milled bar group

Active Comparator

干预措施: milled bar (Procedure)

结局指标

主要结局

marginal bone loss

时间窗: time of insertion, 6 months, 1 year and 3 years

次要结局

  • prosthetic complications as denture fracture, adjustment of denture margins, acrylic teeth wear/fracture, abutment fracture, abutment screw loosening/fracture, prosthetic screw loosening/fracture, metal housing loosening/wear, clip wear/replacement(3 years)
  • mucosal complications include; mucositis/soreness of mandibular mucosa, ulcer of mandibular mucosa, hyperplasia under the bar(3 years)

研究者

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

Salsabeel A Afifi, PhD

lecturer of oral medicine and periodontology

Fayoum University

研究点 (1)

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