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临床试验/CTRI/2024/07/069898
CTRI/2024/07/069898已完成Phase 3 4

Comparative Evaluation of Clinical and Radiographic Outcomes of Three different Scaffolds in Regenerative Endodontic Treatment: A Randomised Clinical Trial

ICMR1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
发起方
ICMR
入组人数
15
试验地点
1
主要终点
Clinical outcomes

研究概览

简要总结

Regenerative Endodontic Treatment (RET) serves as a viable treatment option for the management of non-vital immature teeth and allows for continuation of root development, thickening of the dentinal walls and resolution of any signs and symptoms. The scaffold used in RET contributes significantly to the success of this procedure as it provides a matrix for regeneration of the cells.

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
7.00 Year(s) 至 16.00 Year(s)(—)
性别
All

入选标准

  • Children with non-vital immature permanent teeth requiring endodontic treatment ASA I and II Patient Compliant Patient and Parent.

排除标准

  • Post/core required for final restoration Patient Allergic to any medicaments or antibiotics to be used during the procedure.

结局指标

主要结局

Clinical outcomes

时间窗: Time intervals | At Baseline | 1 Month Post Procedure | 3 Months Post Procedure | 6 Months Post Procedure | 1 year Post Procedure

Resolution of signs and symptoms like pain, swelling, pus drainage, tooth

时间窗: Time intervals | At Baseline | 1 Month Post Procedure | 3 Months Post Procedure | 6 Months Post Procedure | 1 year Post Procedure

mobility

时间窗: Time intervals | At Baseline | 1 Month Post Procedure | 3 Months Post Procedure | 6 Months Post Procedure | 1 year Post Procedure

Tooth survival

时间窗: Time intervals | At Baseline | 1 Month Post Procedure | 3 Months Post Procedure | 6 Months Post Procedure | 1 year Post Procedure

Restoration of function

时间窗: Time intervals | At Baseline | 1 Month Post Procedure | 3 Months Post Procedure | 6 Months Post Procedure | 1 year Post Procedure

2. Radiographic outcomes

时间窗: Time intervals | At Baseline | 1 Month Post Procedure | 3 Months Post Procedure | 6 Months Post Procedure | 1 year Post Procedure

Resolution of periapical pathology

时间窗: Time intervals | At Baseline | 1 Month Post Procedure | 3 Months Post Procedure | 6 Months Post Procedure | 1 year Post Procedure

次要结局

  • 1 Clinical outcomes(Positive response to pulp vitality tests)

研究者

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Mousumi Goswami

ITS Dental College Hospital and Research Centre Greater noida

研究点 (1)

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