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临床试验/NCT03222219
NCT03222219已完成不适用

Influence of the Implant Insertion Torque on the Primary Stability of Tapered Dental Implants With Deep Spires

International Piezosurgery Academy1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
insertional torque value

研究概览

简要总结

The objective of this observational study is to evaluate the primary stability of dental implants. Clinical insertion torque data with the Implant Stability Quotient will be correlated.

详细描述

In the healing of long bone fractures, the absence of movement between the two parts of the fracture is essential for good healing: the movement, even at the micrometric level, can generate stress and tensions that prevent bone apposition in the gap. Even the primary stability of a dental implant is one of the main preconditions for osseointegration: in fact, during healing, micromovies that exceed the threshold of 100-150 microns can stimulate the growth of fibrous tissue in the bone to implant interface, leading to the failure of the procedure.

It is also known that primary implant stability tends to decrease in the first weeks after placement due to inflammatory response due to surgical trauma before rising when bone recoating phenomena begin to prevail over reabsorption. Attention to implant stability is a crucial factor, especially in cases where immediate or early loading procedures are in place: system stress during chewing or simply related to tongue, cheeks or lips movements can result in micromovements that may lead to the failure of the procedure.

With these assumptions, it is evident that a tool that allows the clinician to have a reliable evaluation of implant stability is the most important one: currently in use are the measurement of the insertion torque of the implant and the resonance frequency analysis. The insertion torque can be defined as the measurement of the resistance that the system encounters during its advancement in the apical direction by means of a rotating movement on its axis. Resonance frequency analysis is a not invasive method that evaluates rigidity of the bone system by measuring the size of the implant movement under a lateral force. High insertion torques have been proposed as a first rate technique to achieve a great implant stability, especially in cases to be treated with immediate or early load; Other studies point out that excessive insertion torques can cause both biological problems and mechanical to the implant.

However, the relationship between insertion torque and implant stability is unclear: according to some in vitro studies, the two elements would be in direct relation, while others would be independent.

The purpose of this prospective study is to evaluate in vivo the relationship between insertion torque value and implant stability measured using resonance frequency analysis in dental implants with a deep spire conical design.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • indications for insertion of dental implants, based on careful diagnosis and treatment plan;
  • presence of a residual bone crest with a height ≥ 11 mm and thickness ≥ 6 mm at the site of the implant site planned;
  • the bone crest must be intact (at least 3 months after the loss / extraction of the corresponding dental element);
  • age of the patient more than 18 years;
  • patients should be able to examine and understand the protocol of study;
  • informed consent.

排除标准

  • acute myocardial infarction in the last six months;
  • uncontrolled clotting disorders;
  • unmanaged diabetes (HBA1c superior than 7.5%);
  • radiotherapy in the head / neck district for the last 24 months;
  • Immune compromise (HIV infection or chemotherapy over the last 3 years);
  • active or past treatment with intravenous bisphosphonates;
  • psychological or psychiatric diseases;
  • abuse of alcohol or drug use;
  • unregulated periodontal disease;

结局指标

主要结局

insertional torque value

时间窗: during surgery

registration of torque values with dedicated device

次要结局

  • implant stability quotient(during surgery)
  • clinical assessment(12 months after surgery)
  • radiographic assessment(6 months after surgery)

研究者

发起方
International Piezosurgery Academy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mr. Claudio Stacchi, DDS, MSc

President of the Academy

International Piezosurgery Academy

研究点 (1)

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