Regenerative Endodontic Procedure of Immature Permanent Teeth With the Use of Autologous L-PRF: a Pilot Controlled, Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.
研究概览
简要总结
This study evaluates the impact of autologous 'leucocyte and platelet rich fibrin' (L-PRF) on the periapical bone healing and further root development of infected immature permanent teeth. In the test group regenerative endodontic procedure (REP) is performed with L-PRF as scaffold, in the control group REP without L-PRF is performed .
详细描述
Regenerative endodontic procedures are biologically based procedures designed to restore function of a damaged and nonfunctioning pulp by stimulation of existing stem and progenitor cells present in the root canal and/or the introduction and stimulation of new stem and dental pulp progenitor cells into the root canal under conditions that are favorable to their differentiation and reestablishment of function. L-PRF has the potential advantage of creating a bioactive construct that stimulates the local environment for differentiation and proliferation of these stem and progenitor cells. We have designed this confirmatory study to test the hypothesis that the use of L-PRF in REP of infected permanent immature teeth will accelerate periapical bone healing and stimulate the root maturation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of Informed Consent
- •Permanent immature teeth with weak root canal walls (hopeless prognosis)
- •Patients younger than 25 years
排除标准
- •- Unlikely to be able to comply with the study procedures, as judged by the investigator.
- •Patients older than 25 years
- •Deciduous teeth
- •Permanent (immature) teeth that can be treated by a "regular" root canal treatment/ apexification
- •Known or suspected current malignancy
- •History of chemotherapy within 5 years prior to study
- •History of radiation in the head and neck region
- •History of other metabolic bone diseases
- •A medical history that makes REP unfavorable
- •Involvement in the planning and conduct of the study
- •Previous enrolment in the present study
研究组 & 干预措施
REP with L-PRF
The first REP session will be performed as described by Diogenes et al. (2013). For the second REP-session a venipunction will be performed before the endodontic treatment. 2 to 4 tubes of blood will be collected per tooth. These blood samples will be put into a centrifuge for 12 minutes at 2700 rpm. Fibrin clots will be collected after centrifugation and inserted in the root canal with endodontic pluggers. Medcem Portlandcement (GmbH, Swiss) will be used instead of mineral trioxide aggregate in the second session, to prevent tooth discoloration.
干预措施: stem and progenitor cells (Biological)
REP with L-PRF
The first REP session will be performed as described by Diogenes et al. (2013). For the second REP-session a venipunction will be performed before the endodontic treatment. 2 to 4 tubes of blood will be collected per tooth. These blood samples will be put into a centrifuge for 12 minutes at 2700 rpm. Fibrin clots will be collected after centrifugation and inserted in the root canal with endodontic pluggers. Medcem Portlandcement (GmbH, Swiss) will be used instead of mineral trioxide aggregate in the second session, to prevent tooth discoloration.
干预措施: REP with L-PRF (Procedure)
REP
A REP will be performed on immature infected permanent teeth, as described in the protocol of Diogenes et al. (2013). Medcem Portlandcement (GmbH, Swiss) will be used instead of mineral trioxide aggregate in the second session, to prevent tooth discoloration.
干预措施: REP (Procedure)
结局指标
主要结局
Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.
时间窗: 3 years
次要结局
- Amount of root development or maturogenesis,by measuring:(3 years)