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临床试验/NCT07150858
NCT07150858招募中不适用

Comparison Between Erythropoietin-enhanced Albumin Platelet-rich Fibrin and Albumin Platelet-rich Fibrin in Transcrestal Sinus Lifting With Simultaneous Implant Placement

Alexandria University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年5月25日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Change in pain scores

研究概览

简要总结

Background: 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 trans crestal sinus lifting with albumin platelet rich plasma.

Aim of the study: To compare between erythropoietin and albumin platelet rich fibrin transcrestal sinus lifting versus albumin platelet rich fibrin transcrestal sinus lifting using piezoelectric device in patients with atrophic maxilla.

Methods: This study will be carried out as a randomized

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
None

入排标准

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

入选标准

  • Residual bone height not less than 5 mm measured from crestal bone to sinus floor.
  • Both genders.
  • Good oral hygiene
  • No previous surgery or radiation treatment on the maxillary sinus

排除标准

  • Recent radiation therapy in maxilla.
  • Uncontrolled systemic diseases such as diabetes mellitus.
  • Heavy smoker (those who smoke ≥ 25 cigarettes a day).
  • Alcohol abuse.
  • Patient on anticoagulant drug
  • Severe allergic rhinitis.
  • Tumor or large cyst in the maxillary sinus.
  • Oroantral fistula.
  • Presence of acute or chronic sinus pathoses or sinus membrane perforation.(

结局指标

主要结局

Change in pain scores

时间窗: up to 14 days

pain will be assessed through a 10 point visual analogue scale (VAS). (0-1=none, 2-4=mild, 5-7=moderate, 8-10=severe).

Change in edema

时间窗: up to 14 days

Edema will be assessed as follows: 1. None (no swelling) 2. Mild (intraoral swelling confined to the surgical field) 3. Moderate (extra oral swelling in the surgical zone) 4. Severe (extraoral swelling spreading beyond the surgical zone)

Change in implant stability

时间窗: immediate and 4 months

implant stability will be assessed using ostell device

次要结局

  • Change in bone gain(baseline and 4 months)
  • Change in bone density(baseline and 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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