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临床试验/NCT03814070
NCT03814070Unknown不适用

Prosthesis and Implant Survival in Immediately Loaded Full Arch Restorations Using Fiber Reinforced Versus Non-reinforced Temporary Frameworks: A Randomized Clinical Trial

Nermeen Ahmed Hassan0 个研究点目标入组 114 人开始时间: 2019年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
114
主要终点
Prosthesis survival

研究概览

简要总结

In immediate loading of implants of completely edentulous patients, the most common post-surgical complication following the surgery noted in the dental literature is fracture of the provisional restoration with rates ranging from 4.17% to 41%. Most of these fractures occur because polymethyl methacrylate (PMMA) materials are inadequate and have low rigidity to withstand extended periods of heavy occlusal use.

Fractures of full arch provisional restorations during healing are concerning, because they eliminate cross-arch stabilization and disrupt stress distribution patterns which might jeopardize implant osseointegration affecting the survival rates for implants. Therefore, it is important to look for another material that has higher rigidity than PMMA and can withstand masticatory forces for extended periods without fractures or load concentration on the implants during the osseointegration period.

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
None

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Completely edentulous patients.
  • Patients with proper amount of attached gingiva (≥2 mm)

排除标准

  • Patients having a medical condition that absolutely contraindicates implant placement.
  • Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (HbA1c). (greater than 6.4 percent)
  • Potentially uncooperative patients who are not willing to go through the proposed interventions.
  • Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
  • Patients with history of bruxism
  • If insertion torque for the implants is less than 35 Ncm

研究组 & 干预措施

Non-reinforced full arch acrylic restorations

Active Comparator

干预措施: No framework (Procedure)

full arch acrylic restorations with fiber-reinforced framework

Experimental

干预措施: Fiber-reinforced framework (Procedure)

结局指标

主要结局

Prosthesis survival

时间窗: 4 months

Clinical evaluation of any fracture in the prosthesis

次要结局

  • Peri-implant crestal bone loss during healing(4 months)
  • Implant survival(4 months)

研究者

发起方
Nermeen Ahmed Hassan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nermeen Ahmed Hassan

PhD candidate

Cairo University

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