Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Success of articaine buccal infiltration.
研究概览
简要总结
The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis.
详细描述
This study aims to evaluate the effectiveness of preoperative administration of Diclofenac Potassium (50 mg Cataflam) compared to placebo, one hour before treatment, on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis. Patients with moderate-to-severe pre-operative pain are selected. Full medical and dental history will be obtained from all patients treated during this study by the operator. Clinical diagnosis of symptomatic irreversible pulpitis is to be confirmed. The primary outcome is success of buccal infiltration using articaine.The secondary outcomes are pain on injection. Patients will be recruited from the outpatient clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active pain (moderate-to-severe) in mandibular molars.
- •Patients with prolonged response to cold testing and electric pulp tester.
- •Patient with the ability to understand and use pain scales.
- •Patient with vital coronal pulp tissue on access.
- •Patient who accept to enroll to the study.
排除标准
- •Patients' allergies or any other contraindication to diclofenac potassium or articaine.
- •Pregnant and lactating females.
- •Patients having pain medication in the last 6 hours.
- •Patient has more than one symptomatic mandibular tooth in the same quadrant.
- •Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
- •Patients with active peptic ulcer and gastrointestinal disorders.
- •Patients with history of bleeding problems or anticoagulant use within the last month.
研究组 & 干预措施
Diclofenac Potassium 50mg tab
Diclofenac Potassium 50mg (Cataflam) tablet to be administered one hour before treatment.
干预措施: Diclofenac Potassium 50mg Tab (Drug)
Placebo
Placebo to be administered one hour before treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Success of articaine buccal infiltration.
时间窗: Intraoperative
Success of buccal infiltration using articaine. It will be measured using Heft-Parker visual analogue scale. The success will be considered if patient experienced no or mild pain (Heft-Parker VAS rating less than 54mm) while the failure will be considered if patient experience moderate-or-severe pain (Heft-parker VAS rating greater than 54mm) during access into dentin, access into pulp chamber or instrumentation of the canals.
次要结局
- Pain on injection(Intraoperative)
研究者
Amatallah Hussein Nasser Al-Rawhani
Postgraduate Student in Endodontic Department/ Faculty of Oral and Dental Medicine/ Cairo University.
Cairo University