3D Instrumentation Versus Rotary Instrumentation
The Effect of 3D Instrumentation Versus Rotary Instrumentation on Postoperative Pain and Bacterial Reduction in Necrotic Oval Canals: A Randomized Clinical Trial
enrollment of the patient after diagnosis, radiographic evaluation, and signing the informed consent.
allocation of the patient to either intervention or control group. After anaesthesia and access cavity, the first root canal sample will be taken. Endodontic treatment will be completed in one visit. The second root canal sample will be taken. Patients will be asked to evaluate their postoperative pain level using VAS scale at 6, 12, 24 hours, and daily up to 5 days. Patients will record the number of analgesics if any taken.
研究概览
详细说明
After diagnosing the case as asymptomatic pulp necrosis and confirming that the patient conforms to all eligibility criteria, (R.S) will enroll the patient in the study.
the operator will complete treatment of all cases in single visit as following:
- Anesthetizing the tooth using inferior alveolar nerve block technique
- Removal of Caries and/or coronal restorations completely with sterile bur and rubber dam will be applied.
- Preparation of access cavity using another sterile round carbide bur size 3 and Endo-z bur .
- (R.S) will take the preinstrumentation root canal sample (S1)
- Confirming the patency of the root canals using stainless steel hand K-files size #10 and #15 . Working length will be determined .
- In the intervention group, (R.S) will perform mechanical preparation in a 3D manner using Xp-endo Shaper single file in an endodontic motor at a speed of 800 rpm and a torque of 1 Ncm.
- In the control group, mechanical preparation will be done using rotary iRace files (#25/0.04, #30/0.04, and #40/0.04) at a speed of 600 rpm and a torque of 1.5 Ncm. The canal will be irrigated and recapitulated after the use of each instrument.
- EDTA gel will be used as a lubricant. The canals will be thoroughly irrigated using 3ml of 2.5% sodium hypochlorite.
- The canal will then be dried by using sterile paper points and then flushed with 5 ml of 5% sodium thiosulfate to inactivate the NaOCl. The postinstrumentation sample (S2) will be taken from the canals.
- Master cones will be fitted to the working length and a radiograph will be taken to ensure proper length.
- (R.S) will complete obturation using AdSeal resin-based root canal sealer .
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Manial
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Cairo、Manial、埃及、11553
- Faculty of oral and dental medicine - cairo university
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy Adult patients.
- Age between 20-40 years old.
- Males & Females.
- Asymptomatic necrotic mandibular premolars with or without periapical radiolucency.
- Normal occlusal contact with the opposing teeth.
- Patients accepting to participate in the study.
Exclusion criteria:
- Medically compromised patients
- Pregnant women
- If analgesics or antibiotics have been administrated by the patient during the past 12 hours preoperatively
- Patients reporting bruxism or clenching
Teeth that shows:
- Association with acute periapical abscess and swelling
- Greater than grade I mobility or pocket depth greater than 5mm
- No restorability
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：XP-endo Shaper
The XP-endo Shaper is an innovative single instrument manufactured from Max wire.
Its special ability to shift crystalline structure at body temperature in order to adapt to the root canal wall, has provided a unique instrument with the promise of anatomical shaping.
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mechanical preparation in a 3D manner using Xp-endo Shaper
其他名称：
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有源比较器：iRace
rotary files
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rotary mechanical preparation
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative Pain
大体时间：up to 5 days
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Degree of postoperative pain will be measured by the patients using modified VAS
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up to 5 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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intracanal bacterial reduction
大体时间：6 hours
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The intra-canal bacterial count will be determined using culture technique in the microbiological department, Cairo University. Samples in RTF vials will be dispersed with vortex for 30 seconds by the laboratory technician. The RTF solution will be serially diluted one-tenth dilution and spiral plated onto the agar medium. The plates will be incubated at 37ₒc aerobically and anaerobically. The resultant anaerobic growth will be quantified by evaluating the colony forming units (CFU) on the agar medium under the microscope and the number of CFU per milliliter of each dilution will be calculated for each sample. |
6 hours
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Incidence of analgesic intake
大体时间：up to 5 days
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In case of presence of moderate or severe postoperative pain, (R.S) will instruct the patients to take only one capsule of placebo given to him/her at the end of the visit (Powdered milk packed in opaque capsules)
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up to 5 days
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合作者和调查者
调查人员
- 首席研究员：Radwa Emara、Faculty of oral and dental medicine - cairo university
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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