NCT05599087招募中1 期
Encapsulated Acellular System From Mesenchymal Stem Cells for Endodontic Treatment of Patients With Apical Periodontitis: Phase I Clinical Trial.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Regeneration of dental pulp
研究概览
简要总结
To evaluate the security and efficacy in the administration of encapsulated acellular system derived from Mesenchymal Stem Cells as a novel regenerative endodontic procedure which to promote the pulpar regenration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy patients (ASA I).
- •Patient presenting with a maxillary or mandibular incisor/canine and mandibular premolar with mature apex, pulpal necrosis, and apical radiographic evidence of apical periodontitis (PAI ≥2 and CBCTPAI ≥1).
- •Patient presents with a tooth that does not respond to electrical and thermal pulp testing.
- •Patients with restorable teeth (considering the definition of class A or B, according to Samet and Jotkowitz classification) without the need for a single fine prosthesis (crown) or major restoration.
排除标准
- •Patients not available for the follow-up period (27 weeks).
- •Patients who will undergo orthodontic treatment in the next six months.
- •Patients with reports of allergies to any material or medication used in the study.
- •Pregnant patients.
- •Heavy smokers (more than 10 cigarettes per day).
- •Patients with a history of systemic diseases that impair immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's and Cushing's disease.
- •Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study. Or that they will be irradiated or undergo chemotherapy.
- •Patients who have endodontically treated teeth.
- •Patients who have teeth with signs of severe root resorption.
- •Patients who have teeth with mobility class III or Dens invaginatus.
- •Patients who have teeth with a history of avulsion-type dentoalveolar trauma.
- •Patients who have teeth with clinical and/or radiographic evidence of root fracture.
- •Patients who have teeth that cannot be completely isolated with rubber dam.
- •Patients who have teeth with more than one root or root canal.
结局指标
主要结局
Regeneration of dental pulp
时间窗: 6 months
Patients are expected to have a decrease in the size of the periapical lesion in some of the three dimensions, or an increase of no more than 0.1 mm in one of them, when evaluating radiographic and cone beam computed tomography (CBCT) .
次要结局
未报告次要终点
研究者
研究点 (2)
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