Novel Collagen Scaffold vs Conventional Scaffold in Regeneration of Human Dental Pulp Tissue
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Observation 2 - Increase in dentin wall thickness. It is noted that minimal change is expected over the course of this short-term study.
研究概览
简要总结
The purpose of this investigation is to assess the use of a novel scaffold (an FDA-approved collagen-hydroxyapatite material called Syn-Oss) for regeneration of pulp tissues versus the use of a traditional scaffold (blood clot).
详细描述
Regeneration of pulp tissues in teeth with immature roots is a new concept based on historical limited success using calcium hydroxide dressings placed into debrided pulp spaces. Obtaining stem cells from the apical papilla (SCAP cells), which are present at the base of all teeth, but are most accessible in teeth with immature apices, greatly enhances clinical success. Current therapies lack ideal messenger chemicals and scaffolds to optimize results.
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single root canal space apparent on a standard dental periapical radiograph
- •Immature tooth apex width at least 1.1mm in diameter as measured from the radiograph
- •No history of antibiotic drug allergy
- •Necrotic pulp as demonstrated by coronal discoloration.
- •Periapical radiolucency
- •Negative pulp sensibility tests
- •Other standard clinical means of assessing pulp vitality status
排除标准
- •Any patients having an American Association of Anesthesiologists 4 health classification will be excluded.
研究组 & 干预措施
Collagen-hydroxyapatite Scaffold (Syn-Oss)
Placement of a collagen-hydroxyapatite scaffold (Syn-Oss), placement of a tricalcium silicate barrier (mineral trioxide aggregate), placement of a composite occlusal restoration (standard dental material).
干预措施: Collagen-hydroxyapatite scaffold (Syn-Oss) (Drug)
Collagen Scaffold (Colla-Plug)
Placement of a collagen scaffold (Colla-Plug) over a blood clot, placement of a tricalcium silicate barrier (mineral trioxide aggregate), placement of a composite occlusal restoration (standard dental material). The Colla-Plug material is placed adjacent to the blood clot that has formed inside the root canal space. It act as a matrix for the subsequent placement of the mineral trioxide aggregate material. It has been used as the standard of care in regenerative endodontics since 2004.
干预措施: Collagen Scaffold (Colla-Plug) (Drug)
结局指标
主要结局
Observation 2 - Increase in dentin wall thickness. It is noted that minimal change is expected over the course of this short-term study.
时间窗: Months 3-6, patient recruitment and revascularization surgery in Department of Endodontics
Grade 1 = dentin wall thickness increased by \> 1mm Grade 2 = dentin wall thickness \< 1mm
Observation 1-Radiodensity at apex @ 1mm from root vertex
时间窗: Month 0-3, Institutional Review Board proposal and approval
Grade 1 = no disruption of apical anatomy Grade 2 = Periodontal ligament (PDL) width double thickness, with intact lamina dura Grade 3 = break in lamina dura
Observation 4 - Periradicular status
时间窗: Month 13-15, data analysis and manuscript preparation
Grade 1 = no periradicular radiolucency Grade 2 = periradicular radiolucency 0-1 mm in diameter Grade 3 = periradicular radiolucency \> 1 mm in diameter
Observation 3 - Increase in root length, in mm.
时间窗: Month 6-12, clinical and radiographic recall and assessment
Grade 1 = root length increased \> 1 mm Grade 2 = root length increased 0-1 mm Grade 3 = root length shorter than pre-op
次要结局
未报告次要终点
研究者
David Clanton DMD
Principal Investigator
University of Alabama at Birmingham