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临床试验/NCT06011031
NCT06011031进行中(未招募)不适用

Mechanical and Biological Assessment of Two Different Attachment Materials in Maxillary Implant Retained Overdenture In-Vivo Study

Ain Shams University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
14
试验地点
2
主要终点
bone level change around implants

研究概览

简要总结

The aim of the current study is to assess the effect of two types of attachments (Locator, Novaloc) on the supporting structures both mechanically using stress strain analysis and biologically through measuring bone height using cbct.

详细描述

14 Completely edentulous patients will be divided into two groups each group contains seven patients: Group One: Each patient will be restored with 4 implant retained maxillary overdenture using Peek retention inserts attachment system and Bone Level Ti-Zr implants.

Group Two: Each patient will be restored with 4 implant retained maxillary overdenture using Nylon retention insert attachment system and Bone Level Ti implants.

Bone height in millimeters will then be evaluated around each implant using cone beam computed tomography at the time of placement of attachments, 6 months, 1 year

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 (Investigator)

盲法说明

all selected patients were restored with a complete denture prosthesis and then wer devided using random allocation software into 2 groups

入排标准

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

入选标准

  • Completely edentulous patient with u shaped dental arch.
  • Systemically free.
  • Patients completed all extraction at least 6 months before surgery.
  • Patients Tempromandibular joint is free from any disease.
  • Patient's mouth opening is proper for accessibility during surgery and implant placement.
  • Sufficient bone level (length, and width) at implant placement site.
  • Presence of enough bone height at implant site close to the maxillary sinus.
  • Absence of sinus pneumatization.

排除标准

  • Heavy smoker.
  • Patients with bone diseases.
  • Patients having a history of parafunctional habits.
  • Patients with diabetes mellitus.
  • Patients on chemotherapy or radiotherapy.
  • Patients on any medications that reduce wound healing.
  • Patients without sufficient bone level (height, width).
  • Patients with sinus pneumatization.

结局指标

主要结局

bone level change around implants

时间窗: Through study completion an average 1 year.

measurement of bone height mesial, distal to each implant

次要结局

  • patient satisfaction(Through study completion an average 1 year.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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