NCT04093583已完成3 期
Randomized Clinical Trial, Conventional Treatment-controlled, Studying the Efficacy of Plasma Rich in Growth Factor (PRGF®) in Alveolar Ridge Preservation After Simple Exodontia in the Anterior Region of Maxilla.
Fundación Eduardo Anitua5 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年11月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 5
- 主要终点
- Bone regeneration
研究概览
简要总结
This RCT aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation in the aesthetic zone. The control group is the spontaneous healing occuring after the suturing of the alveolus. The primary endpoint is the bone regeneration measured in biopsies obtained from the regenerated alveolar bone.
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
- Single (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
- 否
入选标准
- •- Subjects of both sexes with an age greater than or equal to 18 years.
- •Clinical indication for a simple exodontia in the aesthetic zone (from left 2nd premolar to the right 2nd premolar in the maxilla).
- •Need of a dental implant placement in the extraction site.
- •Availability to follow-up during the treatment period
- •Subjects with non-active periodontal disease.
- •Buccal dehiscence < than 25% in the vestibular table
排除标准
- •- Presence of an active infection
- •Loss of any plate of the socket
- •Severe inflammation in the area of the exodontia previous to the intervention
- •Have previous diagnosis of a coagulopathy.
- •Have previous diagnosis of any autoinmune disease.
- •Have received radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to inclusion
- •Regular treatment with AINES or other antiinflammatory drugs
- •Previous history of chronic hepatitis or heatic cirrhosis
- •Positive markers for VHC, AgHBs, VIH I/II or Treponema pallidum
- •Uncontrolled diabetes mellitus (Glycosylated hemoglobin higher than 9%)
- •Subjects submitted to hemodyalisis
- •Presence of malignant tumour, haemangiomas or angioma in the exodontia region.
- •Previous history of ischemic cardiopathy in the last year.
- •Pregnancy or womens in childbearing age who do not take contraception measures.
- •Nursing womens
- •Metabolic bone disease
- •Ongoing treatment with biphosphonates both through oral or intravenous administration
- •Smoking habits (> 10 cigarrettes/day)
- •In general, any disability to participate in the study
研究组 & 干预措施
Simple suture
Active Comparator
干预措施: Exodontia (Procedure)
PRGF-Endoret
Experimental
干预措施: Exodontia (Procedure)
PRGF-Endoret
Experimental
干预措施: Alveolar ridge preservation with a PRP (PRGF-Endoret) (Drug)
PRGF-Endoret
Experimental
干预措施: Preparation of PRGF using Endoret technology (Device)
结局指标
主要结局
Bone regeneration
时间窗: 12 months
Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation
次要结局
未报告次要终点
研究者
研究点 (5)
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