Effect of Preoperative Single Dose of Sodium Ibuprofen Versus Placebo on Post-operative Pain for Patient With Symptomatic Irreversible Pulpitis Related to Mandibular Molar Teeth: Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
The aim of this study is to clinically compare post-operative pain levels after administration of preoperative single dose of sodium ibuprofen versus placebo for patient with symptomatic irreversible pulpitis related to mandibular molar teeth.
详细描述
Oral pharmacologic agents have been the primary option, and the use of drugs has increased exponentially. Many pharmacological agents have been used to manage endodontic pain, including Non-steroidal Anti-inflammatory Drugs (NSAIDs),.administration of NSAIDs before root canal treatment will reduce inflammatory process before it begins. NSAIDs are widely used to control post endodontic pain They act by blocking the activity of cyclooxygenase (COX 1 and 2) enzyme. In human dental pulps with irreversible pulpitis, a higher level of expression of COX 2.In cases of irreversible pulpitis NSAIDS can be administered preoperatively since they reduce the level of prostaglandinE2(PGE2) which is responsible for sensitization of nociceptors. Ibuprofen is one of the most commonly used NSAIDs and a potent inhibitor of prostaglandin (PG) synthesis that can manage various pain types and has anti-inflammatory activity. Enhancements in ibuprofen acid's pharmacokinetics have led to the development of ibuprofen salts with a faster dissolution rate and onset of action. These ibuprofen salts.Fast acting ibuprofen like Sodium ibuprofen delivers maximum plasma drug concentrations at about 30-40 min, compared with around 90-120 min for standard ibuprofen acid formulations
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
- Double (Participant, Care Provider)
盲法说明
drug will be put in sealed envelop and assistant supervisor will generate random sequence
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients above 18 years old and below
- •Male or female
- •Patients seeking root canal treatment
- •Mandibular posterior molarteeth with Symptomatic irreversible pulpitis .
- •Spontaneous pain
- •Systematically healthy patient(ASA I,II)
排除标准
- •Medically compromised patients having significant systemic disorders. (ASA III or IV)
- •History of intolerance to NSAIDS.
- •Patients with two or more adjacent teeth requiring endodontic treatment.
- •External root resorption
- •Internal root resorption
- •Vertical root fracture
- •Periapical lesion
- •Pregnancy
- •Use of ibuprofen in the last 12 hour
- •Bleeding disorder
- •Long term corticosteroid use
- •Mobility Grade II or III.
- •Pocket depth more than 5mm.
- •Previous root canal therapy.
- •Non-restorability
- •Temporomandibular joint (TMJ) problems, bruxism, clenching or traumatic occlusion.
- •Inability to perceive the given instructions.
研究组 & 干预措施
nurofen
sodium ibuprofen 1 tablet (256) 30 minutes before treatment administered once (oral)
干预措施: nurofen (Drug)
placebo
starch tablet 30 minutes before treatment administered once (oral)
干预措施: nurofen (Drug)
结局指标
主要结局
postoperative pain
时间窗: Post-operative pain will be assessed immediately after treatment ,at 6 hours, at 12 hours, at 24 hours and 48 hours
pain will be measured by visual analogue scale(VAS). Postoperative pain levels were documented by the patients immediately after obturation, 6, 12, 24 and 48 hours post-treatment. The VAS consists a 10-cm line anchored by 2 extremes, ''no pain'' and ''pain as bad as it could be.'' Patients were asked to make a mark on the line that represents their level of perceived pain. Readings were transformed into categories; no pain (range of 0-4mm), mild pain (range of 5-44mm), moderate pain (range of 45-74mm) and severe pain (range of 75-100mm)
次要结局
- need for rescue medication(Amount of analgesics taken by the patient after root canal treatment, up to 48 hours postoperatively)
研究者
Samah Sobhie Abdalla
principal investigator
Cairo University