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临床试验/NCT02733861
NCT02733861Unknown不适用

Evaluation of the Related Factors Influencing the Stability of Dental Implants

Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1
试验地点
1
主要终点
Implant stability quotient (ISQ) was tested by Osstell™ Mentor

研究概览

简要总结

With the development of oral medicine,dental implants has become a very popular solution to remediate the loss of teeth and dental rehabilitation. For the last few decades, the immediate loading protocol have become more and more popular because the increasing demands of shortened treatment time. Implant stability is considered one of the most important parameters in implant dentistry. It affects the healing and successful osseointegration of implants. For any implant procedure, successful implant integration is a prerequisite criterion, which depends on a series of procedure-related and patient-dependent factors. It also has been considered that preoperative measurement is critical and may give valuable information to predict loading time and survival of the implants.

In this clinical study, the samples were collected from patients with single teeth missing who came from the department of prosthodontics from the School of Stomatology of the Fourth Military Medical University.The prospective cohort study was used to investigate the correlation between different factors and the early stability of the implants. And then, using the correlation between different factors and the early implant stability gives predictable data about implant stability and then evaluate the accuracy and reliability.

详细描述

Ethical and institutional approval was obtained from the study institution. From May 2015 to May 2017, teeth missing consecutive patients requiring implant treatment consented to participate in this study to investigate the correlation between implant stability and bone density.

Cone beam computed tomography (CBCT) was used for preoperative radiological evaluation of the jawbone for each patient, and then bone density in Houndsfield units scale was assessed by SimPlant Pro 11.04 software. Immediately after the implant placement and 12 weeks later, stability measurements were performed with Osstell™ Mentor.The captured data was represented in a quantitative unit called Implant Stability Quotient (ISQ) on a scale from 1 to 100 and averaged for each implant.

The descriptive statistical methods were used to show the differences in bone density and ISQ values among location, gender, age and implant diameter variables. Mann-whitney test was used for comparison of HU values and ISQ values between different age and gender groups. Kruskal-Wallis test was used for comparison of HU values and ISQ values between different location and implant diameter groups. The changes of ISQ values over time were compared using Wilcoxon signed rank test. The Spearman's rank correlation coefficient was used to investigate the correlation between ISQ values and HU values.

At last, to investigate the possible correlations between implant stability and bone density and to study the feasibility of predicting implant stability by using preoperative CBCT.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the patients who had undergone tooth extraction within the previous 3 months

排除标准

  • those who required bone augmentation simultaneously with implant insertion, and patients with any systemic disease

结局指标

主要结局

Implant stability quotient (ISQ) was tested by Osstell™ Mentor

时间窗: on the 12th weeks after surgery

The transducer probe was aimed at the small magnet on top of the SmartPeg at a distance of 2 to 3 mm and held stable during the pulsing time until the instrument beeped and displayed the ISQ value. If two ISQ values were displayed simultaneously, their mean value was recorded. Measurements were taken twice in the buccolingual direction as well as in the mesiodistal direction. The mean of all measurements was rounded to the nearest whole number and was regarded as representative of the ISQ.

次要结局

  • Measure the thickness of the bone around the implant by CBCT.(immediately after the surgery)
  • Measure the crestal bone resorption by X-ray images(immediately and 3 months after the surgery)
  • Measure the bone density of the implant locations by CBCT.(within 10 days before surgery)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhang Yumei

Professor

Air Force Military Medical University, China

研究点 (1)

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