Comparative Evaluation of Bacterial Reduction Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars: An In Vitro and In Vivo Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Intracanal Bacterial Load Reduction
研究概览
简要总结
The primary aim of the study is to compare the bacterial reduction in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation.
详细描述
This study aims to compare the antibacterial effectiveness of a single rotary file system with conventional manual instrumentation during pulpectomy of primary molars. The study will evaluate bacterial reduction by microbiological culture techniques using colony-forming units per milliliter (CFU/mL) before and after chemo-mechanical preparation.
This investigation will include both in vitro and in vivo components to provide a comprehensive evaluation of bacterial reduction. In the clinical part of the study, children aged 4 to 6 years with restorable mandibular second primary molars diagnosed with irreversible pulpitis will be recruited from the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department at the Faculty of Dentistry, Cairo University. Eligible teeth will undergo pulpectomy and will be randomly assigned to one of two groups:
Group 1: Pulpectomy using a single rotary file system. Group 2: Pulpectomy using conventional manual stainless-steel K-files.
Microbiological samples will be collected from the root canals before instrumentation and after completion of chemo-mechanical preparation using sterile paper points. The samples will be transferred to brain-heart infusion broth and cultured on agar plates under aerobic and anaerobic conditions. Bacterial growth will be quantified by counting colony-forming units to determine the degree of bacterial reduction produced by each instrumentation technique.
The findings of this study will contribute to evidence-based decision-making in pediatric endodontics by clarifying whether rotary instrumentation provides superior bacterial reduction compared with manual instrumentation in primary molar pulpectomy. Improved understanding of the antimicrobial effectiveness of these techniques may help clinicians select instrumentation methods that enhance treatment success, reduce chairside time, and improve patient cooperation during pediatric dental procedures.
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)
盲法说明
The blinding of operator is not possible due to the nature of the technique used
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children age 4 to 6 years
- •Medically free children
- •Cooperative children
- •Restorable mandibular second primary molars with signs or symptoms of irreversible pulpitis
- •No internal root resorption on radiograph
- •No external root resorption on radiograph
- •No periapical radiolucency
- •No inter-radicular radiolucency
排除标准
- •Uncooperative children
- •Children with systemic disease
- •Children with physical disability
- •Children with mental disability
- •Refusal to participate
- •Inability to attend follow-up visits
- •Refusal to sign consent form
- •Previously accessed teeth
- •Mobile mandibular primary molars
- •Pain on percussion
- •Swelling on palpation or in the vestibule
研究组 & 干预措施
Rotary Instrumentation Group
Single Rotary File System
干预措施: Rotary Instrumentation (Procedure)
Manual Instrumentation Group
Manual Stainless Steel K-File Instrumentation
干预措施: Manual Instrumentation (Procedure)
结局指标
主要结局
Intracanal Bacterial Load Reduction
时间窗: Immediately before instrumentation and immediately after completion of chemo-mechanical preparation during the same treatment visit.
Reduction in intracanal bacterial count after chemo-mechanical preparation during pulpectomy of primary molars. Microbiological samples will be collected from the root canals before instrumentation (S1) and after completion of instrumentation (S2) using sterile paper points. Samples will be cultured on brain heart infusion agar plates, and bacterial growth will be quantified by counting colony-forming units (CFU). The difference in CFU between S1 and S2 will be used to determine the level of bacterial reduction achieved by rotary instrumentation compared with manual instrumentation.
次要结局
- Clinical success(At 3, 6, and 12 months)
- child's behavior level.(Immediately after treatment.)
- Instrumentation time(during the procedure, starting from anesthesia till end of procedure)
- Postoperative Pain(at 6, 12, 24, 48, and 72 hours and 1 week after treatment.)
研究者
Aya Gamal Abd Elzaher
candidate in department of pediatric dentistry and dental public health department, faculty of dentistry, Cairo university
Cairo University