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临床试验/NCT01400321
NCT01400321Unknown不适用

PEERS Multicenter OsseoSpeedTM TX Profile Implant: German Astra Soft Tissue (GAST) Maintenance Study An Open, Prospective Observational Study to Evaluate Implant Stability, Marginal Bone and Soft Tissue Maintenance of the Astra Tech Dental Implant System: OsseoSpeedTM TX Profile Implant in Patients With Tooth Loss in the Aesthetic Zone or the Posterior Atrophied Mandible

Johannes Gutenberg University Mainz28 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
28
主要终点
Implant survival

研究概览

简要总结

The open, prospective, non-controlled observational study is designed to provide information on the short-, medium- and long-term clinical performance of the Astra Tech OsseospeedTM implant surface in combination with a special implant design. The study will provide information on implant survival and soft tissue and bone maintenance as clinical performance of the OsseoSpeedTM TX Profile Implant in the aesthetic zone or the posterior mandible with socket like atrophy.

详细描述

Within the new OsseoSpeedTM TX Profile Implant from Astra Tech a special surface modification treated with diluted hydrofluoric acid is combined with an inclined implant-abutment interface to support soft tissue and marginal bone maintenance in the aesthetic zone or the socket like atrophy in the mandible. Pre-clinical studies of the OsseospeedTM modification support improvement in osseointegration. Both aspects are of special clinical interest in critical situations e.g. reduced bone quantity and quality or in case of socket atrophy with loss of the papillae. The outcome variables of interest are implant survival and the marginal bone and soft tissue response for clinical evaluation of the OsseoSpeedTM TX Profile Implant from Astra Tech. In contrast to the original treatment protocol with a healing period of 3 and 6 months for maxilla and mandible, respectively, the healing period is reduced to 3 months following the recent literature with equal clinical results. Within the present study implants will heal in a transgingival mode and loaded after a healing period of 3 months. For special indications in the aesthetic zone the implants may optionally be loaded following an early loading protocol, which comprehend temporary loading within 48h after implant insertion. Overall implant survival rates are high. However, for implants placed immediately after tooth extraction in the esthetic zone or in the socket like atrophied mandible survival rates are lower. The special physiology of bone resorption in the aesthetic zone exhibit high requirements for soft tissue and bone maintenance for good clinical long term results. Differences in pattern of marginal bone response have been described for different implant systems. The extend of bone loss as also the pattern of remodeling as reaction to OsseospeedTM surface and the special shape of the OsseoSpeedTM TX Profile Implant will be investigated within the present study.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • loss of tooth aesthetic zone (a maximum of 4 implants)
  • loss of tooth at the distal mandible (distal canine) (a maximum of 4 implants)
  • presence of inclined alveolar ridge profile
  • antagonists are natural teeth or fixed prosthesis

排除标准

  • < 18 years
  • Tumour or irradiation
  • bisphosphonate or cortisone intake
  • Diabetes mellitus
  • Mental illness or disorder with affection of compliance
  • Consumption of > 20 cigarettes/day
  • Acute Mucosal infection or illness (e.g. acute Parodontitis, Pemphigus, Lichen)
  • Relation of Crown to Implant ratio of > 1
  • No clinical primary stability of the implant after insertion

结局指标

主要结局

Implant survival

时间窗: after 24 months

How many implants are in situ after an observational period of 24 months (2 years). Data presentation will be a Kaplan Meier Estimate.

次要结局

  • Marginal bone adaption(after 24 months)
  • Pinc aesthetic parameter(after 24 months)
  • periodontal parameter(after 24 months)
  • Detection and description of implant related complications and other adverse and serious adverse events(over the study period (24 months))

研究者

发起方
Johannes Gutenberg University Mainz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Dr. Wilfried Wagner

Prof. Dr. Dr. Wilfried Wagner

Johannes Gutenberg University Mainz

研究点 (28)

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