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临床试验/NCT03558347
NCT03558347Unknown不适用

5 Year Clinical Evaluation of CONELOG® Screw-Line Implants With 7 mm Length: a Prospective Randomized Double-blinded Clinical Study

RWTH Aachen University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
marginal bone loss

研究概览

简要总结

The objective of this prospective, randomized, pilot study is to determine whether the Conelog® connection is suitable for splinted/non-splinted cemented crowns in the chewing centre (focus only on implant-abutment connection) and whether implants with the Conelog® connection and a length of 7mm are suitable for use in the molar region of the lower jaw.

详细描述

In order to avoid sinus augmentation in the upper jaw and a vertical augmentation in the lower jaw, various manufacturers offer short implants of 6-8mm length. The prevention of augmentative measures, especially in the mandible, is a fundamental component of the minimization of invasiveness while at the same time improving the functional capability. The benefit lies in the possibility to place implants without prior bone augmentation even in difficult anatomical conditions. This significantly reduces the invasiveness which on the one hand allows a higher number of patients to be treated with implants (especially morbid patients and anxiety patients) and on the other hand makes the treatment more predictable, with less risk, cost-efficient and considerably faster. Moreover, new scientific insights are gained in the area of short implants.

As with all implants, the risks associated with the study consist of intraoperative complications (e.g. damage of adjacent structures), failure of the implant (e.g. impairment of wound healing, fracture of the implant body), the abutment or abutment screw (e.g. loosening, fracture), or the crown on the abutment (veneer fracture, scaffold fracture).

The objective is to determine whether implants with the Conelog® connection and a length of 7mm are suitable for splinted/non-splinted monolithic lithium disilicate crowns cemented on individualized titanium abutments in the chewing centre of the mandible. The main indication for short implants is severe atrophy of the jaw, which creates a longer distance from the implant shoulder to the occlusal plane. An unfavourable crown-to-implant ratio means higher stress on the screws, the implant-abutment surface and possibly on the osseointegration of the implants. This raises the question whether splinted crowns have a positive effect on implant survival compared to non-splinted crowns.

The two 7mm Conelog ® implants are either used in the area of the second premolar and the first molar or the first and second molars of the mandible. The diameter of the implant depends on the width of the alveolar bone and ranges from 3.8 to 4.3 mm.

In case of a bilateral free-end situation, both quadrants are treated as part of the study, and both treatment variants are applied by using splinted crowns on one side and individual crowns on the other (split mouth design).

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

入选标准

  • female and male subjects older than 18 years
  • absence of all molars and, optionally, the second premolar in at least on quadrant of the lower jaw
  • the periodontal situation of the other teeth is healthy or periodontal treatment has already been successfully performed
  • the antagonists are natural teeth or treated with fixed dentures
  • good health according to the ASA Physical Status Classification System one or two (ASA 2010)
  • good oral hygiene and an at most moderate tobacco consumption
  • bone height above the N. alveolaris inferior of at least 11mm and the precondition of a one-stage implantation and augmentation
  • signed consent

排除标准

  • Indication for large augmentations of the jaw bone
  • Bone abundance with minimal risk of injury to neighbouring structures when using two 11 mm or longer implants
  • Psychological disorder
  • substance abuse
  • removable dentures (with or without implants)
  • pregnancy
  • patients under age or unable to reason
  • persons who are placed in an institution on a judicial or administrative order

结局指标

主要结局

marginal bone loss

时间窗: 5 years

measurement of marginal bone loss on standardized radiographs \[mm\]

次要结局

  • survival rate of prosthetic restoration(5 years)
  • gingival status(5 years)
  • oral hygiene(5 years)
  • probing depth(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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