the Effect of Intraligamentary Injection of Lornoxicam on the Intensity of Post-operative Endodontic Pain in the Tooth With Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post operative endodontic's pain
研究概览
简要总结
To determine the effect of intraligamentary injection of Lornoxicam on the intensity of post-operative endodontic pain in the tooth with symptomatic irreversible pulpitis.
详细描述
sixty qualified samples (initial estimate which will be come more accurate after the pilot study on 6 patients) will be divided randomly in three groups which all of them will have an inferior Alveolar injection and before the beginning of the treatment the primary group will receive an injection of 0.4 mL ( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) of Lornoxicam and the second group will be injected with 0.4 mL of normal saline( 0.2 mL in mesio buccal and 0.2 mL in disto buccal) ,in third group we will only pretend the injection but actually there is no substance injected ,making the patient believe that there was an injection . Then the patients' pain will be evaluated with visual Analogue Scale analysis (VAS) 0-170 mm in time intervals of 6, 12, 24 and 48 hours after the treatment.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy (ASA I, II);
- •Patients with first or second mandibular molars who need endodontic treatment;
- •Vital tooth without a history of past endodontic treatment;
- •Patients with clinical evidence of irreversible Pulpits with moderate to severe pain;
- •Patients without pre apical lesion and periodontal ligament enlargement more than 0.75-1mm on the x-ray images;
- •Patients in the age group of 18-65 years old
排除标准
- •Pregnant or nursing;
- •necrotic tooth;
- •Patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or NSAIDs;
- •People who have a history of acute peptic ulcer, during the past 12 months;
- •People who have bleeding problems or have been taking anticoagulant drugs over the past month;
- •Patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs.
研究组 & 干预措施
Lornoxicam
干预措施: Lornoxicam (Drug)
normal saline
干预措施: normal saline (Drug)
no injection
干预措施: no injection (Drug)
结局指标
主要结局
Post operative endodontic's pain
时间窗: 6,12,24,48 hours after drug's injection
The measuring method of the pain is VAS(Visual Analogue Scale).
次要结局
未报告次要终点
研究者
Mandana Abedi Tari
principal investigator
Islamic Azad University, Tehran