Effect of Addition of 0.5 Mol/L Mannitol to 0.5% Bupivacaine on IANB Success and Post-endodontic Pain in Mandibular Molars With Irreversible Pulpitis: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
研究概览
简要总结
Inferior alveolar nerve block using either 0.5% bupivacaine alone or in addittion to mannitol in patients with irreversible pulpitis in mandibular molars.
详细描述
Patients with irreversible pulpitis in mandibular molars will be selected according to the eligibility criteria and patients are then randomized to either using 0.5% bupivacaine alone or in addition to mannitol. Anesthetic success and postoperative pain will then be assessed.
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
- 17 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients; age between 17-35 years old.
- •Males or Females.
- •Medically-free patients
- •Patients suffering from symptomatic irreversible pulpitis without apical periodontitis in mandibular molar teeth.
- •Positive patients' acceptance for participation in the study.
排除标准
- •Patients who had any analgesic during proceeding 12 hours before the treatment.
- •Teeth with necrotic, infected pulp, swelling or symptomatic apical periodontitis (apical abscess).
- •Pregnant females.
- •Patients with history of significant medical conditions (contraindication of mannitol use).
- •Addiction
- •Psycological disturbance.
研究组 & 干预措施
bupivacaine plus mannitol
0.5% bupivacaine with 1:200,000 epinephrine plus 1.5 ml of 0.5 mol/L mannitol
干预措施: bupivacaine plus mannitol (Drug)
bupivacaine alone
0.5% bupivacaine with 1:200,000epinephrine alone
干预措施: bupivacaine alone (Drug)
结局指标
主要结局
Postoperative pain intensity ranging from 0-10 where 0 means no pain, 10 the worst pain
时间窗: 72 hours
using pain scale ranging from 0-10 where 0 means no pain, 10 the worst pain
次要结局
- Anesthetic success(1 hour)
- lip numbness duration(24 hours)
- Medication intake(72 hours)
研究者
Safeya AbdelRahaman Hassan
assistant lecturer
Cairo University