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临床试验/NCT05721612
NCT05721612已完成不适用

Evaluation of the Use of Titanium Platelet-rich Fibrin in Sinus Floor Elevation Through Flapless Transcrestal Approach ( a Randomized Controlled Clinical Trial)

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Change in bone density

研究概览

简要总结

Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence flapless transcrestal sinus floor elevation is minimally invasive technique which is used in moderately defected maxilla.

Aim of the study: to evaluate both clinical and radiographic outcomes in sinus floor elevation following dental implant placement using flapless transcrestal sinus lift approach with Titanium platelet rich fibrin (TPRF) as a sole sinus graft material compared to Platelet rich fibrin (PRF).

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • •Patient seeking replacement of a missed maxillary posterior teeth by a delayed dental implant procedure.
  • •Residual bone height is (4-7) mm measured from crestal bone to sinus floor.
  • •Good oral hygiene

排除标准

  • •Uncontrolled Diabetes.
  • •Coagulation disorders.
  • •Immunological disorders.
  • •Previous radiation of the head and neck region.
  • •Abnormal bone physiology.
  • •Therapy with Bisphosphonates.

研究组 & 干预措施

Study group

Experimental

干预措施: Flapless transcrestal sinus lift approach with TPRF (Other)

Control gorup

Active Comparator

干预措施: Flapless transcrestal sinus lift approach with PRF (Other)

结局指标

主要结局

Change in bone density

时间窗: Baseline and 6 months

Cuts of CBCT (cross sectional, axial and sagittal view), bone density, will be analyzed using On-demand software. The radiographic evaluation will be based on radiological parameters, using reference points and lines at T0 and T1.

次要结局

  • Change in implant stability(Baseline and 6 months)
  • change in pain scores(1st day, 3rd day and 1 week)

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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