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临床试验/NCT05166434
NCT05166434Unknown1 期

Radiographic Assessment of Crestal Maxillary Sinus Membrane Elevation Using Different Dental Implant Heights in Atrophic Posterior Maxilla

Cairo University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
1 期
入组人数
32
试验地点
2
主要终点
Measuring bone formation and density beyond apical part of dental implant after closed sinus lifting

研究概览

简要总结

This study is aiming to evaluate primary stability and bone gain in trans-crestal osseodencification technique using Regular concaved osteotomes at different height elevations.

详细描述

For those patient who need up to 2-6 mm of vertical height, the 1-stage transcrestal osteotome technique shown to be stable over long term.

The most important negative factor that can be inferred from the results is that BAOSFE becomes less predictable when there is 4 mm or less of preexisting alveolar bone height beneath the sinus. Moreover, more challenging situation is the magnitude of tapping force, which may accidently perforate the antral membrane causing a lot of complication in the naso-antral apparatus by excessive taping force. The expansion of the osteotomy sites is performed with a number of Concave tipped tapered osteotomes with increasing diameters that are applied through the edentulous alveolar crest at the inferior border of the maxillary sinus floor. With each insertion of a larger osteotome, bone is compressed, pushed laterally and apically while pushing the garnered bone apically beneath the tented membrane.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

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 with edentulous vertically deficient posterior maxillary ridge a minimum 4 mm height of alveolar bone, and 6 mm in width.
  • Both males as well as females without any active periodontal disease.
  • All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
  • All selected patients are non-smokers and non-alcoholics.
  • Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
  • The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
  • Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

排除标准

  • On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
  • General contraindications to implant surgery.
  • Subjected to irradiation in the head and neck area less than 1 year before implantation.
  • Untreated periodontitis.
  • Poor oral hygiene and motivation.
  • Uncontrolled diabetes.
  • Pregnant or nursing.
  • Substance abuse.
  • Psychiatric problems or unrealistic expectations.
  • Severe bruxism or clenching.
  • Immunosuppressed or immunocompromised.
  • Treated or under treatment with intravenous amino-bisphosphonates.
  • Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
  • Active infection or severe inflammation in the area intended for implant placement.
  • Need of bone augmentation procedures at implant placement.
  • Unable to open mouth sufficiently to accommodate the surgical tooling.
  • Patients participating in other studies, if the present protocol could not be properly followed.
  • Referred only for implant placement or unable to attend a 5-year follow-up.
  • Requiring only single implant-supported crowns.

结局指标

主要结局

Measuring bone formation and density beyond apical part of dental implant after closed sinus lifting

时间窗: 4 months after Dental implant placement

CBCT superimposition of the Pre-operative and Post-operative

次要结局

  • Measuring secondary stability of dental implants(4 months after Dental implant placement)

研究者

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

Maher Mohammed Hebah Maqbol

Principle investigator

Cairo University

研究点 (2)

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