NCT04945629已完成3 期
Randomized Clinical Trial, Controlled by Conventional Treatment, of Plasma Rich in Growth Factors (PRGF®) in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.
Fundación Eduardo Anitua1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年9月2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
- 44
- 试验地点
- 1
- 主要终点
- Bone regeneration
研究概览
简要总结
This Randomized Clinical Trial aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation after single molar extractions. 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
- •Age> 18 years
- •Clinical indication for simple tooth extraction in the posterior sectors (from the second premolar to upper and lower second molars)
- •Need to place a dental implant in the same position of the extraction
- •Availability of observation during the period of treatment
- •Signature of the informed consent
排除标准
- •Third molars
- •Active periodontal disease
- •Simultaneous extraction of two adjacent pieces in the same quadrant
- •Oral dehiscence ≥ 25%
- •Alveolus depth <7mm
- •Loss of some wall of the alveolus
- •Severe inflammation in the extraction area
- •Previous diagnosis of coagulopathies
- •Previous diagnosis of autoimmune disease
- •Be receiving, or have received the 30 days prior to extraction treatment with radiotherapy, chemotherapy, immunosuppressants, systemic corticosteroids or anticoagulants
- •Regular treatment with NSAIDs
- •History of chronic hepatitis or liver cirrhosis
- •Positive markers for HCV, AfHBs, HIV-I / II or TP
- •Diabetes mellitus with poor metabolic control (evidence of glycated hemoglobin> 9%)
- •Dialysis treatment
- •Presence of malignant tumors, hemangiomas or angioma in the extraction area.
- •History of ischemic heart disease in the last year
- •Pregnancy or women of childbearing age who do not take action contraceptives
- •Lactating women
- •Previous diagnosis of metabolic bone disease
- •Antiresorptive treatment
- •Treatment with monoclonal antibodies
- •Smoker> 10 cigarettes / day
- •Any inability to participate in the study
研究组 & 干预措施
Simple suture
Active Comparator
Atraumatic exodontia followed by simple suture
干预措施: Blood clot and simple suture (Drug)
PRGF-Endoret
Experimental
Atraumatic exodontia followed by simple suture
干预措施: Alveolar ridge preservation with a PRP (PRGF-Endoret) (Drug)
结局指标
主要结局
Bone regeneration
时间窗: 12 weeks post-extraction
Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation
次要结局
- Inflammation score(3, 7 and 15 days post-extraction)
- Soft tissue healing index(3, 7 and 15 days post-extraction)
- Changes in the dimension of the alveolar ridge(12 weeks post-extraction)
- Soft tissue histomorphometric changes(12 weeks post-extraction)
- Change in the bone dimensions of the alveolar ridge(12 weeks post-extraction)
- Change in bone density(12 weeks post-extraction)
- Vitamin D levels(12 weeks post-extraction)
- Frequency of surgical and postsurgical complications(12 weeks post-extraction)
- Visual Analogue Score (VAS)(3, 7 and 15 days post-extraction)
研究者
研究点 (1)
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