Effect of Different Intraligamentary Injections on the Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Post operative pain
研究概览
简要总结
This study will aim to evaluate postoperative pain after intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine and 2% lidocaine given to the patients with symptomatic irreversible pulpitis after completion of the first appointment. Objectives: 1. To evaluate postoperative pain in patients receiving intraligamentary injections of either dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine or 2% lidocaine. 2. To compare the postoperative pain in different groups.
详细描述
The patients will receive a primary Inferior alveolar nerve block injection using 1.8 mL of 2% lidocaine with 1: 80 000 epinephrine using a direct Halsted approach. The needle will be inserted until bony resistance is felt. After reaching the target area, aspiration will be performed, and the solution will be deposited over 60 seconds. After 10 minutes, the patients will be asked about the lip numbness. Patients without profound lip numbness will be excluded from the study since the block will be considered as 'missed'. A conventional access opening will be initiated after isolation with a rubber dam. After endodontic instrumentation and placement of temporary restoration, the patients shall receive intraligamentary injections of dexamethasone (4mg/ml), diclofenac sodium (25mg/ml), 0.5% bupivacaine, and 2% lidocaine. The patients will be randomly allocated to treatment groups with the help of an online random generator. The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours, and 72 hours after treatment. The pain score proforma shall be collected at the subsequent visit.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Symptomatic carious exposed mandibular first or second molars.
- •Positive and prolonged response to thermal sensitivity tests and electric pulp tests.
- •Vital coronal pulp on access cavity preparation.
- •American Society of Anesthesiologists class I or II medical history.
- •Ability to understand the use of pain scales.
排除标准
- •Active pain in more than 1 tooth
- •Teeth with fused roots.
- •Radiographic evidence of an extra root.
- •Large restorations with overhanging margins.
- •Full crowns or deep periodontal pockets.
- •Known allergy or contraindications to any content of the local anesthetic solution or NSAIDs
- •History of known or suspected drug abuse.
- •Taking any drugs which could affect the pain perception, e.g, opioids, antidepressants, anticonvulsants, muscle relaxants, anxiolytics, sedatives, NSAIDs.
- •Pregnant or breastfeeding patients.
- •Patients with asthma, gastric ulcers, and bleeding disorders.
研究组 & 干预措施
Intraligamentary injection of dexamethasone
After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone
干预措施: Dexamethasone (Drug)
Intraligamentary injection of diclofenac sodium
After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone
干预措施: Dexamethasone (Drug)
Intraligamentary injection of 0.5% bupivacaine
After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone
干预措施: Dexamethasone (Drug)
Intraligamentary injection of 2% lidocaine
After endodontic instrumentation and placement of temporary restoration, the patients shall receive Intraligamentary injection of dexamethasone
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Post operative pain
时间窗: 2 hours, 6 hours, 24 hours and 72 hours after treatment
The presence of postoperative pain (using Heft Parker visual analog pain scale) will be assessed at 2 hours, 6 hours, 24 hours and 72 hours after treatment.
次要结局
未报告次要终点
研究者
Dr. Vivek Aggarwal
Professor
Jamia Millia Islamia