Evaluation and comparison of effectiveness of single file rotary system vs sequential multi-file rotary system for pulpectomy in primary molars: an in vivo study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1 Instrumentation time (in minutes)
研究概览
简要总结
Pulpectomy in primary molars is performed to retain the tooth in a symptom-free state until exfoliation, preserving arch integrity and function. Conventional hand instrumentation, though widely used, is time-consuming and may lead to procedural errors. Rotary systems, especially pediatric rotary files, have been introduced to improve efficiency and quality of root canal preparation.
This randomized controlled clinical trial aims to evaluate and compare the effectiveness of a single file rotary system and a sequential multi-file rotary system with the conventional hand file system in pulpectomy of primary molars in children aged 4–9 years. Ninety primary molars diagnosed with irreversible pulpitis or pulp necrosis will be randomly allocated into three groups (n=30 each).
Primary outcomes will include instrumentation time (minutes), obturation time (minutes), and quality of obturation (radiographic assessment of voids and extent of fill). Secondary outcomes will assess the influence of baseline variables (age, gender, tooth type).
The study will provide evidence on whether pediatric rotary file systems improve clinical efficiency and obturation quality compared to conventional hand instrumentation, thereby contributing to better patient cooperation and treatment outcomes in pediatric endodontics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 9.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary molars indicated for pulpectomy with chronic irreversible pulpitis or pulp necrosis.
- •Frankl behavior rating score 3 (Positive) or 4 (Definitely positive) more than or equal to two-thirds of remaining root length on the selected tooth.
- •Written informed consent from parent or guardian (child assent where applicable).
排除标准
- •Systemic disease (medically compromised patients) Disruptive behaviour during the procedure Frank dentoalveolar abscess or extra-oral swelling associated with the tooth less than one-third pathologic root resorption of the involved primary molar.
结局指标
主要结局
1 Instrumentation time (in minutes)
时间窗: Instrumentation and obturation times – intra-operative (measured during pulpectomy); Quality of obturation – immediate post-operative (radiographic assessment
2 Obturation time (in minutes)
时间窗: Instrumentation and obturation times – intra-operative (measured during pulpectomy); Quality of obturation – immediate post-operative (radiographic assessment
3 Quality of obturation (voids and extent of fill assessed radiographically immediately after treatment)
时间窗: Instrumentation and obturation times – intra-operative (measured during pulpectomy); Quality of obturation – immediate post-operative (radiographic assessment
次要结局
- Effect of baseline variables (age, gender, tooth type) on outcomes(At Baseline)
研究者
Dr Mehak Behal
Christian Dental College , Ludhiana