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临床试验/NCT03384446
NCT03384446已完成不适用

The Role of Dental Hygiene Procedures in Disruption of Healthy Homeostasis in Tissues Surrounding Dental Implants - Phase I

University of Washington4 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2017年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
4
主要终点
Titanium elution

研究概览

简要总结

Dental implants have revolutionized the field of dentistry, providing improvements in function and esthetics. They are not, however, without risks. Bone loss around implants (i.e. periimplantitis) is an emerging public health concern. Untreated, peri-implantitis leads to implant loss and jawbone defects. Nonetheless, existing therapies have failed to show long-term efficacy. The pathogenesis of peri-implantitis is believed to be of bacterial etiology similar to periodontal disease. Therefore, existing treatments duplicate strategies for the treatment of natural teeth. However, the titanium (Ti) surface of implants is quite dissimilar to teeth. Recent work from our lab has demonstrated that peri-implantitis is associated with increased release of Ti particles around implants. These findings suggest that treatments targeting periimplantitis must be designed around Ti material properties. A gap in knowledge exists regarding the potential triggers of increased Ti dissolution from the implant surface and the mechanisms by which Ti dissolution products amplify peri-implant inflammation. The aim of this study is to determine if the use of tooth-driven treatment approaches increase Ti in the submucosal plaque.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not know which intervention was administered. Outcome assessor will be different than care provider and will be masked.

入排标准

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

入选标准

  • Is the subject ≥ 25 years of age?
  • Does the subject have an implant with a probing depth ≥ 5mm, bleeding on probing, and radiographic bone loss of > 2mm?
  • Is the subject committed to the study and the required follow-up visits?

排除标准

  • Is the subject immune compromised?
  • Is the subject diabetic?
  • Does the subject take steroid medication?
  • Does the subject regularly use non-steroidal anti-inflammatories?
  • Is the subject pregnant or intending to become pregnant during the duration of the study?
  • Has the subject had previous implantoplasty?
  • Did the subject take any antibiotics in the last 3 months?

结局指标

主要结局

Titanium elution

时间窗: 8 weeks

The primary outcome of the clinical trial will be titanium dissolution in periimplant plaque at 8 weeks following treatment quantified using inductively coupled mass spectrometry (ICMS)

次要结局

  • Probing depth reduction(5 months, 12 months)
  • BOP reduction(5 months, 12 months)
  • Bone level changes(5 months, 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giorgios Kotsakis

Assistant Professor, School of Dentistry:Dept. of Periodontics

University of Washington

研究点 (4)

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