The Effect of Different Modalities of Cryotherapy on Post-Operative Pain Level in Patients With Symptomatic Irreversible Pulpitis (Randomized Control Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
Problem statement: The post-operative pain after endodontic treatment. aim of study: The study is aiming to compare postoperative pain after submucosal cold saline injection (submucosal cryotherapy) (SMC) versus intra-canal cryotherapy (ICC) in mandibular single rooted premolars with symptomatic irreversible pulpitis with symptomatic apical periodontitis (SAP). The material and methods: Subjects and methods: sixty patients will be randomly divided into three groups: the SMC group, the ICC group, and the control group. The patients' postoperative pain will be recorded at 12, 24, and 48 hours postoperatively by questioning them. Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Older than age of 18 years
- •Participants willing to commit for the entire period of the trial and Both genders
- •agreed to sign the written consent after full explanation of the study
- •Having a mandibular single rooted premolar tooth with vital pulp
- •These patients were also suffering from symptoms of symptomatic irreversible pulpitis and apical periodontitis, intermittent or continuous sharp pain that lasts longer after removal of the stimulus. on the basis of the clinical symptoms of severe preoperative pain (visual analogue scale)
排除标准
- •Vulnerable group; prisoners, pregnant females, mentally ill, etc…
- •Teeth with open apices
- •A previous root canal treatment
- •Sinus tracts
- •Presence of periodontal pockets >3 mm in the affected tooth
研究组 & 干预措施
Control
participants will receive standard root canal treatment with final flush of normal saline at the room temperature after cleaning and shaping and before obturation.
干预措施: Saline (Drug)
Submucosal cryotherapy infiltration
participants will receive Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5°C before the normal local anaesthetic routine.
干预措施: Saline (Drug)
Intracanal cryotherapy
participants will receive root canal treatment with final flush of cold saline maintained at a temperature of 2 to 5°C
干预措施: Saline (Drug)
结局指标
主要结局
postoperative pain
时间窗: After 48 hours
measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10)
次要结局
- Substance P level(after 24 hour)
研究者
Yara Adel Mohamed Taha
Dr
October 6 University