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临床试验/NCT03745105
NCT03745105Unknown不适用

Comparative Evaluation of the Effect of a Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Cairo University0 个研究点目标入组 42 人开始时间: 2018年12月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
42
主要终点
Post operative pain assessed with the Numerical Rating Pain Scale

研究概览

简要总结

the study is conducted to assess and compare the efficacy of local intraligamentary injection of glucocorticoids(dexamethasone) and NSAID(piroxicam) on reduction of postoperative pain in patients with symptomatic irreversible pulpitis.

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
Single (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy patient (ASA I or II).
  • Mandibular Posterior teeth with:
  • Preoperative sharp pain.
  • Absence of widening in the periodontal ligament (PDL).
  • Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).

排除标准

  • Patients allergic to anesthetics, piroxicam (any other NSAIDs) or dexamethasone (other corticosteroids).
  • Pregnant or nursing females.
  • Patients having significant systemic disorder (ASA III or IV).
  • Hemostatic disorders or anti-coagulant therapy during the last month.
  • Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 hrs before treatment.
  • Retreatment cases.

研究组 & 干预措施

dexamethasone

Experimental

Pretreatment intraligamentary injection of 0.4 mL of 8 mg/2 mL dexamethasone (Dexamethasone, AMRIYA pharmaceutical, Egypt)

干预措施: Dexamethasone sodium phosphate (Drug)

piroxicam

Experimental

Pretreatment intraligamentary injection of 0.4 mL of 20 mg mL-1 piroxicam (Feldene, Pfizer, Egypt)

干预措施: Piroxicam Injectable Solution (Drug)

Mepivacaine HCL

Active Comparator

Pretreatment Intraligamentary injection of 0.4 mL of Mepivacaine HCl 36 mg /1.8 ml + Levonordefrin HCl 0.108 mg/ 1.8 ml (Mepecaine - L, Alexandria Co.-Egypt)

干预措施: Mepivacaine HCL (Drug)

结局指标

主要结局

Post operative pain assessed with the Numerical Rating Pain Scale

时间窗: up to 48 hours after root canal treatment (At 4,6,12,24 and 48 hours after root canal treatment ).

Intensity of pain after endodontic treatment is recorded by the patient using a numerical rating scale(where 0= no pain ,1-3 =mild pain ,4-6= moderate pain and 7-9= severe pain )

次要结局

  • number of analgesics taken by the patient(Until 48 hours after endodontic treatment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Safwa Essam Mohammed Ahmed Abd el-glil

resident at faculty of dentistry cairo university

Cairo University

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