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临床试验/NCT05758337
NCT05758337招募中不适用

Clinical and Functional Rationalization of the Use of Vibropneumostimulation in the Rehabilitation System of Patients After Dental Implantation

Samara State Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
restoration of dentition by installing crowns on the installed implants

研究概览

简要总结

A new comprehensive technique of dental implantation and rehabilitation of patients will be developed and theoretically justified, including an individual dental implant of a dowel system made of non-woven titanium material with through porosity and vibropneumostimulation, which will improve the functional and anatomical results of treatment.

In the complex treatment and rehabilitation of patients after dental implantation, a vibropneumostimulator with vibratodes of its own design will be used, which activate bone remodeling, which will expand the practical application and theoretical knowledge in the field of hardware massage.

详细描述

The aim of the study: to improve the results of treatment of patients after dental implantation by using vibropneumostimulation of periimplant tissues.

In the work, a complex of functional and clinical methods (thermography, radiography, periotestometry) will be used. The following methods will also be used:

  • echosteometry, thanks to which the density of bone tissue in the periimplant zone will be studied, which will allow to study the processes of bone tissue remodulation.
  • radioisotope diagnostics, thanks to which the dynamics of bone metabolism processes around implants will be studied, which will expand the knowledge of the metabolism of jaw bones.

The subject of the study is the remodulation of bone tissue around the implant, which will allow us to develop a new concept of the relationship of processes in the bone tissue around implants of various designs. The study is based on the study and generalization of existing scientific data on surgical treatment of patients, as well as on the assessment of the relevance and degree of development of the topic. To improve the quality of care for patients after implantation, in our research we will use vibro-pneumatic action on the tissues of the upper and lower jaws in the field of implantation by a device of the SamSMU design - a medical vibro-pneumatic stimulator, it will be an automated system for pneumatic wave massage and vibration exposure.

A vibropneumostimulator with vibratodes of its own design will be introduced into clinical practice, which will expand the arsenal of hardware treatment of an implantologist.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The second is a group of subjects whose rehabilitation was carried out by the well-known classical method

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with a history of previous unsuccessful implantations,
  • patients with a history of bad habits,
  • patients with low bone density (CT),
  • patients who have sinus lifting surgery performed simultaneously

排除标准

  • 未提供

结局指标

主要结局

restoration of dentition by installing crowns on the installed implants

时间窗: 4 months

implant stability according to the method of Resonance Frequency Analysis that register magnetic vibrations of the pin together with the implant in the form of an indicator Implant Stability Quotient

次要结局

  • installation of the gumformer(7 months)
  • the beginning of the functional load(7 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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