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临床试验/CTRI/2025/06/088467
CTRI/2025/06/088467尚未招募4 期

Effectiveness of different rotary files during bio-mechanical preparation in primary teeth - A Randomized Controlled Trial.

AIIMS Rajkot1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年6月23日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
Instrumentation time

研究概览

简要总结

Dental caries is one of the prevalent oral diseases in children affecting the overall quality of children. The management of deep dental caries involving the pulp includes the pulpectomy of the specific teeth. There are various instruments suggested for bio-mechanical preparation during pulpectomy in primary teeth. The rotary instruments designed for the permanent teeth are routinely used in primary teeth as well. In addition, the rotary files specific to the primary teeth have also been designed and in use for years. Though there are multiple studies comparing hand instruments to rotary instruments, no studies published that evaluate the effectiveness of rotary instruments designed for permanent teeth and primary teeth.

The eligible participants as per the inclusion and exclusion criteria will be recruited from the OPD of the Department of Dentistry. A random sequence of the experimental materials will be developed before the start of the study, and allocation concealment will be done using sealed envelopes. After obtaining the consent, the pulpectomy procedure will be initiated and the biomechanical preparation will be done with either regular or primary teeth-specific rotary files selected based on the randomisation codes. All the procedures will be done by single experienced Pediatric Dentist. The instrumentation time will be noted by the dental chair assistant and the obturation quality will be noted by an outcome assessor who is blinded to the rotary instruments used.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • •Children in the age group of 5 – 9 years age; Children with primary mandibular second molar teeth that are indicated for pulpectomy; Children with definitely positive or positive behaviour.

排除标准

  • •Specially challenged children and children with primary teeth with internal or external resorptions.

结局指标

主要结局

Instrumentation time

时间窗: Baseline (at the time of intervention)

次要结局

  • Obturation quality(Baseline (at the time of intervention))

研究者

发起方
AIIMS Rajkot
申办方类型
Government medical college

研究点 (1)

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