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临床试验/NCT01060644
NCT01060644已完成不适用

Maxillary Sinus Floor Elevation Following Simultaneous Implant Installation Without Graft Material

Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
CT evaluation before Dental Implant uncovering

研究概览

简要总结

The present study describes and evaluates the surgical protocol for sinus mucosal lining elevation of the maxillary sinus for Dental Implant Insertion without Bone grafting Underneath the Sinus Membrane.

详细描述

Restoration of lost dentition in the severely atrophic posterior maxilla has for the last 2 decades been successfully treated with various sinus augmentation techniques and installation of dental implants. The use of graft material is anticipated to be necessary; however, recent studies have demonstrated that the mere lifting of the sinus mucosal lining and simultaneous placement of implants result in bone formation. This study was conducted in order to evaluate simultaneous sinus mucosal lining elevation and installation of dental implants without any graft material.

The present study describes and evaluates a modification of the surgical protocol for sinus mucosal lining elevation and simultaneous installation of osseointegrated implants with a MIS implant system (Seven ™) ,in 20 patients.

Preoperative Examination: (Screening):

  1. Medical History

  2. Clinical Examination

  3. Oral hygiene.

  4. Oral mucosa condition.

  5. Number of missing teeth in the posterior maxilla.

  6. Radiographic Examination (CT and Panoramic X-ray)

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy patient.
  • Patients that have a rehabilitation dentist.
  • Healthy conditions of Maxillary Sinuses and Oral Mucosa.
  • Healthy bone determined by Panoramic X-ray.
  • Sub-antral bone at least 4 mm as measured on CT.
  • Have a good oral hygiene condition.
  • Patient that does not participate in other clinical study.
  • Patient able to read and understand and sign the informed consent.

排除标准

  • Unhealthy patients, with recorded medical history diseases as: diabetes, mellitus, heart diseases, renal failure, osteoporosis.
  • Patients treated with anticoagulation medication (Coumadin, Plavix).
  • Patients treated with Oral Bisphosphonate drugs (as Fosalan).
  • Patient with a history of Chemotherapy or Radiotherapy treatment.
  • Unhealthy conditions of Maxillary Sinuses.
  • Patient without prosthetic rehabilitation treatment plan ) approved by the referred dentist.

结局指标

主要结局

CT evaluation before Dental Implant uncovering

时间窗: In the end of the treatment

CT evaluation of bone regeneration

时间窗: In the end of each treatment

次要结局

未报告次要终点

研究者

发起方
Carmel Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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