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临床试验/CTRI/2024/12/077649
CTRI/2024/12/077649尚未招募不适用

comparative evaluation of human amniotic membrane and platelet-rich fibrin (prf) for apexogenesis in immature non vital permanent teeth: a randomized controlled study

FACULTY OF DENTAL SCIENCES KING GEORGE MEDICAL UNIVERSITY1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年1月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
28
试验地点
1
主要终点
The clinical outcome will be assessed by checking for symptoms like pain, swelling, or sensitivity, and radiographic outcomes will measure changes in root length and apex width

研究概览

简要总结

Pulp tissue in an immature open-apex tooth has a rich blood supply and contains stem cells that possess a great potential to regenerate in response to damage. Pulp necrosis of an immature tooth as a result of caries or trauma could arrest further development of the root, leaving the tooth with thin and weak walls that are prone to fracture. Endodontic treatment of such a tooth is difficult because thin walls do not allow much instrumentation, and the obturation might not provide predictable apical seal due to the large opening of the apex.

Regenerative endodontics is a novel modality which involves physiological replacement of the damaged structures of tooth like dentin, root and cells of the pulp-dentin complex. These procedures have not only shown to resolve apical periodontitis but continued root development, thus increasing the thickness and strength of the previously thin and fracture-prone roots.

Biological membranes have emerged as a promising tool for regenerative endodontics. These membranes are made of biocompatible materials that can create a barrier or scaffold that supports tissue regeneration and growth. Recently researched tissue engineering materials like platelet-rich fibrin (PRF), platelet-rich plasma (PRP), collagen, give promising results in regenerative endodontics.One such biologically/naturally derived tissue is the Human amniotic membrane (HAM) which has been utilized in the medical field since 1900. The presence of collagen, elastin, laminin and fibronectin makes this membrane an excellent scaffold in tissue engineering. HAM is biologically active due to the presence of growth factors (GF) that aids cell migration and facilitates wound healing.HAM in endodontic procedures, such as pulp capping and periapical surgery, have shown encouraging results.

Considering the regenerative potential of HAM, this study has been designed with the aim to evaluate the efficacy of Amniotic membrane as scaffold for regenerative endodontics will be compared to PRF regarding percentage change in apical width and root length.

AIMS AND OBJECTIVES:

To assess the clinical and radiographic outcomes when using human Amniotic membrane for apexogenesis in immature nonvital permanent teeth.

To compare the efficacy of human Amniotic membrane as scaffold in apexogenesis of immature nonvital permanent teeth as compared to PRF

MATERIALS AND METHODS:

The present study will be conducted in the Department of Conservative Dentistry and Endodontics, Faculty of Dental Science, King George’s Medical University, Lucknow, in collaboration with Department of Paediatric and preventive Dentistry, Faculty of Dental Science, King George’s Medical University, Lucknow.

The study will be conducted only after getting clearance from the Institutional Ethical Committee and registration in CTRI.

Suitable subjects will be selected from the department of Conservative Dentistry & Endodontics and Paediatric & Preventive Dentistry and will be randomly divided into two groups namely Platelet-rich fibrin group and human Amniotic Membrane group. This study includes a structured approach to evaluate the clinical and radiographic outcomes of the treatment and compare with baseline parameters over a specified follow-up period. The trial aims to assess the efficacy and safety of the procedure and the use of the amniotic membrane as a scaffold material in dental regenerative therapy.

The data obtained will be statistically analyzed. Any changes deemed in the interest of the study will be done accordingly.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 25.00 Year(s)(—)
性别
All

入选标准

  • Healthy patient under the age of 25 years with permanent immature non-vital teeth will be included in the study.

排除标准

  • Patients above 25 years Deciduous teeth Permanent immature teeth that can be treated by a conventional root canal treatment/apexifification Known or suspected current malignancy History of other metabolic bone diseases.

结局指标

主要结局

The clinical outcome will be assessed by checking for symptoms like pain, swelling, or sensitivity, and radiographic outcomes will measure changes in root length and apex width

时间窗: 3 , 6 , 12 months

次要结局

  • Decrease in Apical width with regeneration of pulp tissue(12 months)

研究者

发起方
FACULTY OF DENTAL SCIENCES KING GEORGE MEDICAL UNIVERSITY
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sharanya A J

KING GEORGES MEDICAL UNVERSITY

研究点 (1)

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