Comparative Evaluation of Two Different Paediatric Rotary File Systems and Manual K-file in Root Canal Treatment of Primary Teeth (Randomized Clinical Trial and In Vitro Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- The quality of obturation will be assessed by using periapical intra oral radiographic parallel technique
研究概览
简要总结
The aim of the current study is evaluation and comparsion between two different paediatric rotary file systems and Manual K-file both clinically and radiographically .This study consist of two parts:I-In vivo part (RCT) II-In vitro part
The in-vivo part:
Its sample size was found to be 30 primary molars (10 teeth for each group)
Group1: Kedo S plus file study group (The teeth will be instrumented by Kedo S plus file) Group2: Kidzo file study group (The teeth will be instrumented by Kidzo file) Group3: Manual K-file control group (The teeth will be instrumented by Manual K-file)
Pulpectomy of primary molars according the protocol of individual group will be made, after that the teeth will be evaluated Immediately for :
1-Instrumentation time 2-Quality of obturation and evaluated at 1, 3, 6, 12 months for clinical and radiographic success
详细描述
The aim of the current study is to evaluation and comparsion between two different paediatric rotary file systems (Kedo S plus file and Kidzo File) and Manual K-file both clinically and radiographically
Primary Objective:
Evaluation of clinical success, instrumentation time and quality of obturation of two different paediatric rotary file systems and manual K-file system in pulpectomy in primary molars both clinically and radiographically (In-vivo part of the study).
Testing hypothesis:
The null hypothesis (H 0 ): there is no difference in clinical success, instrumentation time ,quality of obturation and apical debris extrusion between the two different pediatric rotary systems and manual K-file system in pulpectomy in primary molars
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 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between the age of 4-7 years.
- •Posterior primary mandibular molars with necrotic pulp or irreversible pulpitis indicated for pulpectomy .
- •Presence of minimum 2/3rd root structure.
- •Adequate restorable tooth structure for further placement of stainless steel crowns.
- •Medically free patient.
- •Patient able to visualize and understand the explained assent with no impairment.
排除标准
- •Teeth of poor prognosis due to presence of an extensive mobility, advanced bone or root resorption.
- •Uncooperative patient
- •parents who refuse to sign informed consent to participate in the study
结局指标
主要结局
The quality of obturation will be assessed by using periapical intra oral radiographic parallel technique
时间窗: from baseline to 12 months
the quality of obturation will be assessed from the obtained x - ray film by visual examination to evaluate it under the following categories: Under filled- Optimal filled- Over filled
clinical outcome through participant clinical examination
时间窗: from baseline to 12 months
Evaluation of participants with clinical success according to Coll and Sadrian criteria for treatment success No pain, No sweeling , No exudate, No abnormal mobility
Instrumentation time
时间窗: immediatly after procedure
time of instrumentation will be measured immediatly by digital watch in seconds
次要结局
未报告次要终点
研究者
Huda Abd jabbar
Assisting teatcher
Ain Shams University