跳至主要内容
临床试验/CTRI/2024/12/078812
CTRI/2024/12/078812尚未招募2/3 期

Comparative Evaluation of Clinical Efficiency of Pediatric Single Rotary File Systems for Pulpectomy in Primary Molars – An In Vivo Study

Lakshmi Prasadh N1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To evaluate the clinical efficiency of

研究概览

简要总结

For themorphologically challenging primary root canals, pulpectomy serves as goldstandard therapeutic treatment. Manual hand files has various limitationssuch as time consuming and occurrence of iatrogenic errors. Rotary filesexclusively for primary tooth were  introduced in India through KEDO Rotary files. Though the dual rotary file systems arehighly successful, the recently introduced single rotary file systems posses abetter features and quality than the former. Among the single rotary files, two different generations are introduced whose clinical efficiency has never been evaluated and we aim to find the better file among the Two generations of single rotary files

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • a)Normal, Healthy Children between 4 to 8 years b)Frankl’s Behaviour Rating 3 (positive), 4 (definitely positive) c)Primary molars with irreversible pulpitis d)Primary molars with no signs of pathological resorption e)IOPA Radiograph examination revealing primary molars with two thirds of each root remaining.

排除标准

  • a)Primary molars with unrestorable crown structures.
  • b)Primary molars with perforated pulpal floor and sinus tract.
  • c)Primary molars with intraoral & extraoral swelling.
  • d)Primary molars with Grade III, IV mobility.
  • e)Children with special healthcare needs.

结局指标

主要结局

To evaluate the clinical efficiency of

时间窗: At Baseline

pediatric single rotary file systems by

时间窗: At Baseline

assessing:

时间窗: At Baseline

Obturation quality

时间窗: At Baseline

Instrumentation time

时间窗: At Baseline

Obturation time

时间窗: At Baseline

次要结局

  • To compare patient discomfort levels in(children during the pulpectomy)

研究者

发起方
Lakshmi Prasadh N
申办方类型
Other [self]

研究点 (1)

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