Evaluation of Postoperative Pain and Bacterial Load Reduction After Canal Preparation With ProTaper Ultimate Versus ProTaper Gold Rotary Systems in Patients With Necrotic Maxillary Premolars (Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 主要终点
- Post Operative Pain
研究概览
简要总结
This study aims to research the effect of different instrument designs by comparing protaper ultimate versus protaper gold systems on root canal preparation by evaluating bacterial count reduction and post-operative pain following single visit treatment in patients with necrotic pulp in maxillary premolar teeth.
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
- 22 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient's age ranges between 22 to 45 years with no sex predilection.
- •Medically free patients.
- •Maxillary permanent premolar teeth:
- •Diagnosed clinically with pulp necrosis.
- •Absence of pain.
- •Radiographic evidence of two roots or single root with double canals.
- •Slight widening in the periodontal membrane space or with peri-apical radiolucency
- •No response to cold pulp tester and ethyl chloride spray.
- •Patients who can understand Modified Visual Analogue Scale (VAS).
- •Patients' acceptance to participate in the trial.
排除标准
- •Medically compromised patients.
- •Pregnant women.
- •If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
- •Patients reporting bruxism or clenching.
- •Teeth with:
- •i. Vital teeth. ii. Single canal maxillary premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling. v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth
- •Immature teeth.
- •Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification, root caries.
研究组 & 干预措施
Protaper Ultimate
干预措施: Instrument Design (Other)
Protaper Gold
干预措施: Instrument Design (Other)
结局指标
主要结局
Post Operative Pain
时间窗: Postoperative pain will be measured by modified Visual Analogue Scale immediately after the end of treatment, and at 6, 12, 24 and 48 hours.
Intensity of pain felt after endodontic treatment recorded by the patient using modified Visual Analogue Scale where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain
次要结局
- Number of needed analgesic tablets in case of intolerable pain(Patient will be contacted after 48 hours after endodontic treatment to know the number of analgesic tablets taken)
- Antibacterial Effectiveness(First as a Baseline (T0): After the access cavity Sample 1 will be taken, after 15 minutes (T1) mechanical instrumentation will be done and Sample 2 will be taken, after 5 minutes from T1 (T2) final irrigation will be done and Sample 3 will be taken.)
研究者
Khaled Hassan Abed
Dentist / Master Degree Student at Faulty of Dentistry, Cairo University
Cairo University