Comparative Evaluation of Two Pediatric Rotary Files and Hand Files In Primary Mandibular Molars With Regard to Obturation Quality and Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the quality of obturation between Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files after pulpectomy in primary mandibular molars
研究概览
简要总结
The goal of this clinical trial is to evaluate and compare the efficacy of Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files for biomechanical preparation during pulpectomy of primary mandibular molars in children aged 5-8 years.
The main questions it aims to answer are:
- Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems result in better obturation quality compared with manual K-files during pulpectomy of primary mandibular molars?
- Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems reduce postoperative pain compared with manual K-files following pulpectomy?
Researchers will compare Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files to determine their effect on obturation quality and postoperative pain.
Participants will:
- Undergo clinical and radiographic evaluation of primary mandibular molars requiring pulpectomy.
- Be randomly allocated to one of three instrumentation groups: Kedo-Nano Plus rotary files, Kedo-S Square rotary files, or manual K-files.
- Receive pulpectomy treatment using the assigned instrumentation technique.
- Undergo radiographic assessment of obturation quality following treatment.
- Have postoperative pain assessed using the Wong-Baker Faces Pain Rating Scale at 6, 12, 24, and 48 hours after treatment.
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
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal, healthy children between five and eight years of age
- •Frankl's behavior rating: positive or definitely positive
- •Primary mandibular molars diagnosed with irreversible pulpitis
- •Intact crown structure suitable for rubber dam placement
- •Intraoral periapical radiograph showing primary molars with at least two-thirds of each root remaining
排除标准
- •Children with special healthcare needs or systemic medical conditions
- •Frankl's behavior rating: negative or definitely negative
- •Primary molars with unrestorable crown structure
- •Teeth with severe mobility or pathological root resorption
- •Children or parents who refused to participate in the study
研究组 & 干预措施
Manual K-file group
Primary mandibular pulpectomy done by manual K- files
干预措施: Pulpectomy (Procedure)
Manual K-file group
Primary mandibular pulpectomy done by manual K- files
干预措施: Manual K files (Device)
Kedo-S Square rotary file group
Primary mandibular pulpectomy done by Kedo-S Square rotary file
干预措施: Pulpectomy (Procedure)
Kedo-S Square rotary file group
Primary mandibular pulpectomy done by Kedo-S Square rotary file
干预措施: Kedo-S Square rotary file (Device)
Kedo-Nano Plus rotary file group
Primary mandibular pulpectomy done by Kedo-Nano Plus rotary file
干预措施: Pulpectomy (Procedure)
Kedo-Nano Plus rotary file group
Primary mandibular pulpectomy done by Kedo-Nano Plus rotary file
干预措施: Kedo-Nano Plus rotary file (Device)
结局指标
主要结局
To assess the quality of obturation between Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files after pulpectomy in primary mandibular molars
时间窗: At the end of the pulpectomy procedure, immediately following obturation.
Quality of obturation will be assessed radiographically following pulpectomy in primary mandibular molars. The obturation will be categorized as optimal fill, underfill, or overfill based on the extent of obturation material in relation to the radiographic apex. The outcome measure will be used to compare the effectiveness of the instrumentation techniques in achieving adequate root canal filling.
次要结局
- To evaluate the intensity of post-operative pain following pulpectomy performed using Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files at the interval of 6,12,24 and 48 hours postoperatively.(From completion of the pulpectomy procedure to 48 hours postoperatively, with assessments at 6, 12, 24, and 48 hours.)
研究者
Pooja Vilas More
Junior resident
Goa Dental College