Encapsulated Mesenchymal Stem Cells for Endodontic Treatment of Permanent Teeth With Apical Lesion: a Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Participats Showing Efficacy (Functionality)
研究概览
简要总结
To compare the dental survival in a period of one year of mature permanent teeth with apical lesion following the administration of encapsulated Mesenchymal Stem Cells under a regenerative endodontic procedure and a conventional root canal treatment.
详细描述
This is a controlled clinical trial designed to evaluate the survival of mature permanent teeth with apical lesion treated with regenerative endodontic procedure (REP) based on encapsulated Mesenchymal Stem Cells in a biological scaffold. The REP will be compared to the conventional endodontic therapy. The REP is based on the use of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial . The study group will use the disinfection protocol, indicated in the clinical considerations for regenerative procedures as recommended by the American Association of Endodontics, using a paste of calcium hydroxide prepared with double-distilled water as intracanal medication, and will be operated with REP using allogeneic stem cells in a scaffold, while the control group will be operated with conventional endodontic therapy alone. This clinical trial pretends to determine the dental survival of the tooth with mature apex and apical lesion, over a period of one year.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 58 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient inclusion criteria:
- •Age: 16 - 58 years old.
- •Signed the informed consent.
- •Non-smoking.
- •Systemically healthy patients
- •Tooth inclusion criteria:
- •Upper and lower incisors, upper and lower canines and lower premolars teeth with mature apex and apical lesion (greater than 2 PAI and 1 CBCTPAI).
- •Teeth that do not response to both electrical and thermal pulp test
- •Teeth that can be restored (as defined by Class A or Class B using Samet and Jotkowitz classification) without the need of a stainless steel crown.
排除标准
- •Patient exclusion criteria:
- •Patients without a phone number for contact during the study.
- •Subjects not available for follow up period (12 months).
- •Patients who are or will undergo orthodontic treatment over the next 12 months.
- •Patients with an allergy to any material or drug used in the study.
- •Patients who are pregnant or lactating.
- •Patients with a history of systemic diseases that alter immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's disease and Cushing.
- •Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study.
- •Tooth exclusion criteria:
- •Endodontically treated teeth
- •Teeth with signs of severe root resorption.
- •Teeth with mobility class III or Dens invaginatus.
- •Teeth with avulsion history and conservation in a dry extraoral medium for more than 1 hour.
- •Teeth with clinical and / or radiographic evidence of root fracture.
- •Teeth that can not be absolutely isolated with rubber dam. . Teeth with more than one root or root canal.
结局指标
主要结局
Number of Participats Showing Efficacy (Functionality)
时间窗: 12 months
Efficacy (functionality) was defined when one year after the intervention, the treated tooth remains in the mouth, without pain to percussion test and with apical bone lesion of equal size in the three senses of space or a decrease in some of them or no more than 0.1 mm increase of one of them.
次要结局
- Change in Pulpal Response(baseline, 6 months, 12 months)
- Change in Apical Lesion Size(baseline, 6 months, 12 months)
- Pain to Percussion(baseline, 6 months, 12 months)
- Numbers of Participants With Adverse Event(6 months, 12 months)
- Pulp Regeneration(baseline, 6 months, 12 months)
研究者
Dra. Claudia Brizuel
Doctor of Dental Surgery
Universidad de los Andes, Chile