Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy :(A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- instumentation time
研究概览
简要总结
Preserving primary teeth is essential for maintaining normal chewing, speech development, and psychological well-being. Successful pulpectomy depends on effective chemomechanical preparation of the root canals while preserving their original anatomy. Although hand files are traditionally used for canal preparation in primary teeth, they are time-consuming and may increase the risk of procedural errors. Nickel-titanium (Ni-Ti) rotary systems have gained popularity because they improve canal shaping and reduce instrumentation time. Among these systems, Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue Wire technology are specifically designed for pediatric use. However, evidence regarding their clinical performance remains limited, highlighting the need to compare their effectiveness, particularly in terms of instrumentation time and obturation quality
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Cooperative children.
- •Children between the ages of four and eight years.
- •Restorable teeth with irreversible pulpitis.
- •Continuous bleeding after amputation of coronal pulp tissue.
排除标准
- •Molars that exhibit physiologic root resorption in excess of one-third.
- •Internal and external root resorption.
- •Presence of dental abscess, sinus tract or excessive mobility.
- •Acute spreading infection/cellulitis not manageable with local treatment.
- •Large periapical/furcation lesion with poor prognosis.
- •Teeth close to natural exfoliation.
- •Children with known allergies to study materials or medications used.
结局指标
主要结局
instumentation time
时间窗: same visit while performing the pulpectomy
The total instrumentation time will be recorded from the start of the procedure until the canals are fully prepared. Timing will begin with the insertion of the first file and will end after the final irrigation. It will be measured in minutes using a stopwatch
次要结局
- obturation quality(same visit after pulpectomy completion)
研究者
Rania Fathy Mohammed Mohammed
principal investigator
Cairo University