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临床试验/NCT02502058
NCT02502058撤回不适用

Observational, Case-Series Study Evaluation of Bone Width and Dental Implant Stability When Using the Densah Bur™ Bone Compaction Process to Prepare Dental Implant Sites

University of Minnesota1 个研究点 分布在 1 个国家开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Bone-ridge width before and immediately after preparation of the implant site when using the Densah Bur.

研究概览

简要总结

The primary objective of this study is to determine if the use of a bone compaction process (osseodensification) (Densah™ bur: Versah Osseodensification Company™) to prepare dental implant sites, in human subjects, results in increased bone-ridge width, increased compact bone in the outer wall of the prepared sites, and dental implant stability.

详细描述

The proposed project will be an observational, case-series study. The investigators anticipate enrolling 40 study subjects. Treatment Procedures: Following initial treatment planning discussions between the dentists and their patients regarding all of their dental treatment options, those patients who opt to have dental implants placed will be approached to discuss participation in the current study. Before entry into the study, the Investigator or an authorized member of the investigational staff will explain to potential subjects the aims, methods, reasonable anticipated benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will be informed that their participation is voluntary and that they may withdraw consent to participate at any time. They will be informed that choosing not to participate will not affect the care the subject will receive for the treatment of their condition. Subjects will be told that alternative treatments are available and that if they decline to take part in the present study that such a refusal will not prejudice future treatment. Those patients who are willing to participate will be scheduled for their initial and follow-up dental implant visits at the School of Dentistry. At the baseline visit the study outcome data will be collected; including: 1) measuring the bone-ridge width, before and after implant site preparation (drilling); 2) intraoral photographs of the prepared opening; 3) dental implant torque readings will be obtained; and 4) ISQ as measure of both initial and the dynamic development of osseointegration (the formation of a direct interface between the dental implant and bone) over time. The ISQ measurements will be collected again at three and six-weeks post treatment.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males and females
  • Ages 18-80 years of age
  • Missing at least one tooth.
  • Capable of giving informed consent

排除标准

  • Patient is a pregnant female
  • Patient smoking more than 5 cigarettes per day
  • Patient has a history of alcoholism or drug abuse during the last 5 years
  • Patient with uncontrolled hypertension or diabetes
  • Patient has a malignant tumor
  • Patient is on daily dose of steroids
  • Patient with history of chemotherapy or radiation for the last 12 months
  • Patient who is immuno suppressed
  • Patient with titanium allergy
  • Subject should not be a homeless person

结局指标

主要结局

Bone-ridge width before and immediately after preparation of the implant site when using the Densah Bur.

时间窗: intraoperative

The width of the bony ridge into which the dental implant will be placed will be measured immediately before drilling the opening with the Densah Bur and then again following completion of drilling but before the dental implant is placed into the prepared opening. These measurements will occur at the time of the implant surgery.

次要结局

  • implant stability quotient (ISQ)(intraoperative , at 3 weeks and 6 weeks post surgery)
  • insertion torque value (ITV)(intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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