The Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-Operative Pain of Asymptomatic Uniradicular Necrotic Teeth (A Double Blind Randomized Clinical Trial).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Post Operative Pain
研究概览
简要总结
The purpose of this study is to determine whether the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic necrotic teeth.
详细描述
This trial is aiming to answer a clinical question whether in patients with asymptomatic necrotic teeth, the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide, reduce postoperative pain and intracanal bacteria or not? trial design will be Randomized, controlled, double blinded, unicenter, parallel, two-arm, superiority trial with 1:1 allocation ratio.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject's age between 18-50 years.
- •Both male and female subjects.
- •Medically free and healthy subjects.
- •Mandibular and maxillary single rooted teeth.
- •Asymptomatic non vital teeth.
排除标准
- •Teeth with acute dentoalveolar abscess.
- •Subjects having more than one tooth that require root canal treatment.
- •Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
- •Pregnant females.
- •Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
- •Teeth with periodontal disease or pulp calcification.
- •Subjects taking chronic pain medications.
研究组 & 干预措施
Control: Calcium Hydroxide
Non-setting Calcium Hydroxide
Test: Triple Antibiotic Paste and Anti-Inflammatory Drug
Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
干预措施: triple antibiotic paste with an anti-inflammatory drug (Other)
结局指标
主要结局
Post Operative Pain
时间窗: after 24, 48, and 72 hour from the end of the first visit.
Visual Analogue Scale (VAS) of post operative pain (The VAS consisted of a 100 mm horizontal ruler without numbers except a "0" at its first part and a "10" in the last part. With "0" indicating the best outcome while "10" the worst outcome. The subjects were asked to mark the point that was equivalent to their pain intensity. The pain levels were classified as no pain \[0\], mild pain \[1-3\], moderate pain \[4-7\] or severe pain \[8-10\] )
次要结局
- Intracanal Bacterial Count(before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication.)
研究者
mohamed omaia ahmed salah
Assistant lecturer in Endodontic departement October 6 University
Cairo University