A Comparative Clinical Evaluation Of Single visit with Multiple visit Regeneration Therapy using, Platelet Rich Fibrin, Collagen, and Collagen-Hydroxyapatite, as a Scaffold.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Inducing root apex formation with single visit to multiple visit regenrative therapy, in a necrotic and asymtomatic immature permanent teeth, devoid of any periapical pathology, with incompletly devloped roots using scaffolds and comparison between them.
研究概览
简要总结
If the pulp tissue of a young tooth is damaged by trauma or by caries to the extent that irreversible pulpitis with significant pulp necrosis is present with or without involvement of periapical area, the physiological development of root is compromised. The consequences of arrested root devlopment are, poor crown root ratio, root with very thin walls, and an open apex, which leads to fracture of tooth.
This study is aimed at inducing root apex formation with single visit to multiple visit regenerative therapy, in a necrotic and asymptomatic immature permanent teeth, with incompletely developed roots using scaffolds and comparison between them.
Revascularization was introduced by Ostby in 1961 and reintroduced in 1966 by rule and winter. It is a biologically based treatment regimen that offers, potential for continuous hard tissue formation in young permanent tooth with necrotic root canal system in addition to incompletely developed root.
Regenerative endodontics are based on 3 core principles of tissue engineering. 1.Appropriate source of stem/progenitor cells 2.Growth factors that are capable of promoting stem cell differentiation. 3.Appropriate scaffolds for the regulation of cell differentiation. Hertwig’s epithelial root sheath cells or cell rests of Mallasez are sufficiently resistence to peri-apical infections and stimulate various stem cells like stem cells from apical papilla (SCAP),periodontal ligament,bone marrow, and multipotent stem cells, under the effect of growth factors like platelet derived growth factor,vasculo-endothelial growth factor,transforming growth factor-beta, to form odontoblasts.
Scaffold will provide a framework for cell growth and differntiation at a local site. A scaffold should be porous (to allow for the placement of cells and growth factors),biocompatible with host tissues and biodegradable.
Natural scaffolds (PRF,collagen,collagen-hydroxyapetite) offer good biocompatiblity and bioactivity. The development of normal sterile granulation tissue within root canal is thought to aid in revascularization and stimulation of cementoblasts and undifferentiated mesenchymal cells at peri-apex leads to deposition of calcific material at apex as well as on lateral dentinal walls
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Necrotic immature asymptomatic permanent teeth, Negative response to hot and cold pulp sensitvity tests, Presence of enough coronal structure for rubber dam isolation, No prior endodontic treatment of involved tooth.
排除标准
- •Patients with medical conditions like cardiac problems, Pregnant patients, Diabetic patients, Patients having Bleeding tendecies,HIV positive patients, Hepatitis-B positive patients.
结局指标
主要结局
Inducing root apex formation with single visit to multiple visit regenrative therapy, in a necrotic and asymtomatic immature permanent teeth, devoid of any periapical pathology, with incompletly devloped roots using scaffolds and comparison between them.
时间窗: 1month, 3months, 6months, 12months. Tooth remain asymptomatic, Increase in the Dentin thickness, Increse on root length, Increase in crown root ratio
次要结局
- Healing Of periapical areas with decrease in radiolucent spaces. Decreased chances of re-infection of same tooth, because of the formation of pulp like tissue within the canal system.(1month, 3months, 6months, 12months.)