Effect of Different Rotary Files Systems on Post-operative Pain and Bacterial Reduction in Lower Single Canal Posterior Teeth With Necrotic Pulp: Prospective Double Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
Postoperative pain after endodontic treatment can affect a patient's quality of life. It is reported that debris extrusion after the instrumentation technique can influence postoperative pain. As a result, the aim of this clinical trial is to compare the recent rotary systems (TruNatomy, ProTaper Ultimate, Hyflex EDM and XP- rise rotary files systems) in terms of apical extrusion defined by post-operative pain and their role in reducing the bacterial count inside the canal
详细描述
One hundred and twenty lower premolar teeth will be included in the study(n=120). Teeth will be randomly assigned to one of the 4 groups(n=30). Preoprative pain will be recorded before root canal treatment. Postoperative pain will be recorded using visual analogue scale (VAS) at 6 hours,12 hours, 1day, 2 days, 3 days, 4 dayse and five days after the root canal treatment. Bacterial count before and after instrumentation will be determined using culturing methods to determine the bacterial count reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically fit
- •Age ranges from 18-65 year
- •Restorable teeth
- •Necrotic teeth and symptoms free
- •Lower premolars teeth (single canal posterior teeth)
- •Necrotic pulps
排除标准
- •Medically compromised
- •Non-restorable teeth
- •Open apex canal
- •The past 12-hour history of analgesic intake before treatment.
- •Patients with a history of antibiotics intake in the last 3 months before treatment.
- •Pregnant females.
- •Symptomatic patient.
- •Pulpal diagnosis is not necrotic pulp.
- •Retreatment cases
研究组 & 干预措施
Single file system: Hyflex EDM
干预措施: Hyflex EDM (Other)
Multifile system: Protaper Ultimate
干预措施: Protaper ultimate (Other)
Multiple files systems:TruNatomy
干预措施: Truanatomy file system (Other)
Single file system: Xp shaper rise
干预措施: Xp shaper rise (Other)
结局指标
主要结局
Postoperative pain
时间窗: at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment
Postoperative pain will be recorded using Visual Analogue Scale (VAS) at 6hours,12 hours, 24 hours, 2 days, 3 days, 4 days and five days after the root canal treatment Visual Analogue Scale (VAS) ranges from 0-10, the lower number the better outcome. 0= no pain 1-3= mild pain 4-6= moderate pain 7-10= sever pain
Bacterial count reduction
时间窗: Sample will be collected before and directly after canal prepeartion
Bacterial count sample will be collected before and after canal prepeartion
次要结局
未报告次要终点
研究者
Ruba Mustafa
Professor associate
King Abdullah University Hospital