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临床试验/NCT01620918
NCT01620918已完成不适用

Soft Tissue Responses Around Nanostructured Calcium-phosphate-coated Implant Abutments on Dental Implants: Histological, Genetic and Clinical Evaluation in Smokers and Non-smokers.

University Ghent2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
The soft-tissue attachment around 2 different surfaces at 4 weeks post-implantation.

研究概览

简要总结

  • Baseline:

  • Standard preparation of the osteotomy

  • Placement of 2 dental implants

  • On each implant one of both types of healing abutments is placed

  • Suturing

  • Standardized radiography to measure bone-levels at baseline

  • Digital impression of the surrounding gingiva with an intra-oral scanner (a non-invasive method) to measure the baseline level of the gingiva

  • 2 weeks after Baseline:

o Removal of the sutures

  • 4 weeks after Baseline:

  • A 2nd digital impression of the soft tissue with an intra-oral scanner

  • Collecting crevicular fluid by placing paperpoints in the provided apertures in the healing abutments for 60 seconds without bleeding.

  • Measuring of the pocket depth in the provided apertures in the healing abutments with an automated probe.

  • Removal of the Healing Abutment with the attached soft tissue en-bloque.

  • Placement of a new, regular, Encode Healing Abutment.

  • 10 weeks after Baseline:

  • Start of standard prosthetic procedure. In this study we expect that the soft tissue attachment (i.e. the gingival attachment) will be stronger and earlier achieved at the nano-structured healing abutments than at the normal, uncoated healing abutments. This would lead to a more stable soft tissue complex on the long rung and thus providing a more predictable aesthetic outcome. Secondly, a stronger attachment would mean a stronger barrier against micro-organisms and might influence the occurrence of peri-implantitis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

  • Patients are eligible for this study if they are in need of minimum 2 dental implants and have sufficient bone to place these implants

排除标准

  • All patients with limited bone
  • Periodontally compromised patients
  • Patients who took antibiotics 3 months before implantation
  • Patients with uncontrolled diabetes
  • Pregnant patients
  • Patients who received radiotherapy in the head/neck region
  • Patients under chemotherapy
  • Patients who had intravenous use of bisphosphonates

结局指标

主要结局

The soft-tissue attachment around 2 different surfaces at 4 weeks post-implantation.

时间窗: at 4 weeks post-implantation

Genetic evaluation (through Polymerase Chain Reaction, PCR, the tissue will be detected for certain growth factors), histomorphometric analysis to measure the actual percentage of the surface on which the gingiva is attached to, clinical evaluation of the strength of the attachment through means of an automated probe.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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