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临床试验/NCT01566227
NCT01566227Unknown不适用

Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants

University of Manitoba2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Patient Satisfaction survey (questionnaires)

研究概览

简要总结

This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.

详细描述

The aim of this study is threefold: i) to evaluate within-subject response to complete lower dentures retained by 1 or 2 or 3 implants fitted with independent overdenture attachments; ii) laboratory evaluation of the retention force generated with 1-2 or 3-implants and study its correlation to patients' response; iii) study the wear pattern of the plastic inserts on the overdenture abutments during each retention mode (i.e. the number of implants used to retain the dentures) and correlate its effects to denture stability.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • subjects completely edentulous on maxilla and mandible for at least a year (w/out dentures)
  • Adult age (25 plus) male or female
  • Stable medical health
  • Ability to participate in the study for at least 3-4 years
  • Able to understand and respond to surveys used in the study
  • Adequate amount of bone in the mandible to receive 3 implants.

排除标准

  • history of drug and alcohol abuse, excessive smoking (more than 1 pack/day)
  • surgical limitations:
  • uncontrolled systemic disease: diabetes, etc.. that may compromised healing
  • irradiated surgical site
  • inadequate bone height and width (re: implant size)
  • inability to undergo minor oral surgery because of health or personal reasons
  • psychological and handicapped conditions that may hinder 4-year involvement (physical handicap conditions)
  • Severe TMDs related to joint pathology

结局指标

主要结局

Patient Satisfaction survey (questionnaires)

时间窗: every 6 months up to three years

Assess efficacy of treatment by analysis of patient's answer to a satisfaction survey.

次要结局

  • Radiographs(every 6 months up to three years)
  • Wear of 1 vs 2 vs 3 GPS retention components on complete dentures.(baseline and 6 months)

研究者

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

IPesun (1)

Department Head, Restorative Dentistry Department

University of Manitoba

研究点 (2)

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