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临床试验/NCT06626776
NCT06626776尚未招募不适用

Extended Platelet Rich Fibrin in Lateral Maxillary Sinus Lifting With Simultaneous Implant Placement.

Mansoura University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
implant stability

研究概览

简要总结

thirty implants will be inserted in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization. The patients will be selected from those attending the outpatient clinic of the Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.

  1. Clinical Evaluation

• Implant stability 2. Radiographic Evaluation Vertical bone gain (VBG)

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 (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patent ostium of maxillary sinus.
  • •Patient with missing one or more posterior maxillary teeth.
  • •Residual bone height of 3-6 mm, measured from the crest of alveolar ridge to the floor of the maxillary sinus at the planned implant site.
  • •A ridge width at the site of implantation of <5mm.
  • •Platelets of normal range.
  • •Good oral hygiene.
  • •Patients in the age frame between 20 years and 60 years old.
  • •No gender preface in selection of the patients.
  • •A minimum crown height space of 8 mm.

排除标准

  • •Active sinusitis, cyst, tumors or root tips at the planned surgical site.
  • •Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
  • •Heavy smoking and alcoholism.
  • •Parafunctional habits such as bruxism and clenching.
  • •Signs of acute infection or pus discharge.
  • •Disturbed occlusion.

研究组 & 干预措施

lateral sinus lift with bone augmenation

Experimental

干预措施: lateral sinus lift with using allograft and collagen membrane (Procedure)

lateral sinus lift with extended platelet rich fibrin

Experimental

干预措施: lateral sinus lift with using exteneded platelet rich fibrin (Procedure)

结局指标

主要结局

implant stability

时间窗: 9 months

the stability of the implants will be evaluated by RFA with the Osstell Mentor device.

Vertical bone height

时间窗: 6 months

vertical bone height will be measured as the distance from the alveolar crest to the new sinus floor at the middle of the implant

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 (1)

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