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临床试验/NCT03272828
NCT03272828已完成不适用

A Prospective Randomized Study on the Immediate Loading of Mandibular Overdentures Supported by Parallel Sided or Tapered Dental Titanium Implants

University of Washington2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年6月15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
48
试验地点
2
主要终点
Difference in Implant Failure Rate Between Parallel Sided and Tapered Dental Implants at 5 Years

研究概览

简要总结

The purpose of the study is to compare two different types of dental implants which will be used to support/retain a removable denture in the edentulous mandible. Subjects will have one implant placed in the midline of the mandible after which the patient's existing denture will be modified to fit the implant. The population of this study consists of healthy edentulous individuals 20-75 years of age who have complete dentures in the upper and lower arch.

详细描述

Titanium dental implants have been frequently used in the rehabilitation of edentulous patients. Implants may provide adequate denture stability, improve oral function and oral health related quality of life. There is evidence that implants supporting fixed and removable prostheses have excellent long term success rates. Factors such as implant surface characteristics, length, diameter and shape (parallel sided or tapered) may play and important role for the outcome of the treatment especially when the immediate loading protocol (loading of the implant the same day it is surgically placed) is utilized. There are reports indicating that dental implants placed according to the immediate loading protocol can be used to support removable prostheses in the mandible. Such protocol would minimize the number of surgical procedures and significantly shorten the overall treatment time. Further, increased oral health related quality of life has been reported from studies on mandibular implant overdentures. Traditionally two implants have been suggested for the support of a mandibular overdenture. However, high patient satisfaction rates and appropriate denture retention have been reported among patients with a single implant placed in the mid-line. It is also important to further evaluate and compare various implant designs to determine clinical outcomes. The two dominating types of implant body design on the market are the parallel-sided (straight) and the tapered (conical) shaped. Both implants have similar threads, and the surgical procedure for placing the implants in the bone tissue is similar, but the drills used have a slightly different design and shape. There are today no randomized controlled studies evaluating differences in outcomes with respect to the external implant design i.e. parallel sided or tapered.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be between 20 and 75 years of age
  • Be edentulous and have both upper and lower complete dentures
  • Present with American Society of Anesthesiologists (ASA) I or ASA II and no medical contraindications to implant treatment
  • Have adequate bone volume for placement of one (1) 4.0 mm diameter titanium dental implant with a minimum length of 10 mm in the symphyseal area (=midline) of the anterior mandible
  • Show absence of pathology such as cysts, infections in the gum tissue or bone and remaining roots.
  • Be able to understand the procedures and have a jaw opening range of 30 mm or more

排除标准

  • Ongoing chemotherapy
  • Previous radiation to head/neck
  • Ongoing corticosteroid medication
  • Ongoing blood thinner medication
  • Ongoing medication with psychopharmacological drugs
  • History of alcohol/drug abuse
  • Remaining teeth/root tips
  • Poor quality /fractured/severely worn dentures that cannot be modified to fit the implant
  • Jaw opening range less than 30 mm

结局指标

主要结局

Difference in Implant Failure Rate Between Parallel Sided and Tapered Dental Implants at 5 Years

时间窗: From implant placement (baseline) to 5 years

Implant failure defined as an implant that has lost osseointegration and no longer is stable and supported by the surrounding bone (no bone to implant contact).

次要结局

  • Implant Stability Quotient (ISQ) Measured at 5 Years(5 years)
  • Bone Loss Measurement at 5 Years(From implant placement (baseline) to 5 years)

研究者

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

Mats Kronstrom

Professor, Department of Restorative Dentistry

University of Washington

研究点 (2)

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