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临床试验/CTRI/2025/07/090359
CTRI/2025/07/090359尚未招募4 期

Laser assisted Modified Apexification procedure for immature non-vital teeth: A randomized controlled trial.

Rajiv Gandhi University of Health Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Biodentine is superior than MTA

研究概览

简要总结

Comparative evaluation of Laser assisted modified apexification for immature non-vital teeth with MTA and Biodentine will be done in 18 months of time for root lengthening and root canal dentin thickness ( Radiographic area) with 50 samples allocated to 25 for each group with lottery method. Prior commencing the study ethical clearance is taken and informed /proxy consent will be taken by participant. Before starting the procedure pre operative CBCT scan will be done to assess the root length and development. Modified apexification is done with laser disinfection and  apical collagen and 3-4mm of apical plug is placed with MTA/Biodentine later, canal space is filled with flowable guttapercha after placing sealer. Post procedure periapical PBM is done at 1st, 3rd, 5th days. CBCT assessment will be done at 6months, 12months, 18months for root length and Radiographic root area.

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
8.00 Year(s) 至 14.00 Year(s)(—)
性别
All

入选标准

  • immature teeth with necrotic pulp Children with Frankl behavior rating 3,4.

排除标准

  • special children Medically compromised children Children with Frankl behavior rating 1,2.

结局指标

主要结局

Biodentine is superior than MTA

时间窗: 6months, 12 months, 18 months

次要结局

未报告次要终点

研究者

申办方类型
Other [university]
责任方
Principal Investigator
主要研究者

Dr Shrutha S P

AMEs dental college hospital and research center

研究点 (1)

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