The Effect of Premedication With Trypsin, Bromelain and Rutoside Combination on the Success of IAN Block and Post Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- Success of Anesthesia
研究概览
简要总结
Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids.
详细描述
Background and Rationale
For patients with irreversible pulpitis, achieving adequate pulpal anesthesia during endodontic therapy is a major concern, posing a considerable difficulty from a clinical point of view as an inadequately anesthetized hot tooth with severe pain will not only elevate the patients' apprehension but will also stress the practicing clinician. Inferior alveolar nerve block (IANB) technique is commonly used to achieve pulpal anesthesia in mandibular teeth. The failure rates of a single IANB block injection of local anesthetic in patients with irreversible pulpitis range between 30 and 90 %.
Several clinical studies identified inflammation as a major cause of failure of local anesthesia and an important component of the pathogenesis of hyperalgesia. The use of both steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs) was investigated to improve the success rates of IANB anesthesia. Combined with the bioflavonoid rutin (Rutoside), the proteases Trypsin and Bromelain have been extensively investigated as alternatives to conventional therapies for pain and swelling associated with diverse conditions.
The aim of the trial To assess the effect of Trypsin, Bromelain and Rutoside combination versus diclofenac potassium or prednisolone or placebo on the anesthetic success of IANB and postoperative pain in patients with symptomatic irreversible pulpitis.
The null hypothesis tested is " In patients with symptomatic irreversible pulpitis in their mandibular molars, there is no difference between Trypsin, Bromelain and Rutoside combination or diclofenac potassium or prednisolone or placebo on anesthetic success and post-operative pain after endodontic treatment."
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with symptomatic irreversible pulpitis.
- •Patients with active pain (moderate-to-severe) in mandibular molars.
- •Males and females.
- •Patient with the ability to understand and use pain scales.
- •Patient who accepts to enroll to the study
排除标准
- •Patients' allergies or any other contraindication to any of the used medications or mepivacaine.
- •Pregnant and lactating females.
- •Patients have been taking pain medication 12 hours earlier.
- •Patient has more than one symptomatic mandibular tooth in the same quadrant.
- •Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
- •Patients with contributory medical history (ASA>II).
研究组 & 干预措施
Steroid Group
Patients will receive a single oral dose of a steroid drug (20 mg prednisolone) 1 hour before treatment.
干预措施: Prednisolone Oral Tablet (Drug)
Trypsin, Bromelain and Rutoside (TBR) Group
patients will receive Trypsin, Bromelain and Rutoside combination (2 tablets of flamogen a combination of Trypsin 48mg, Bromelain 90mg and Rutoside 100mg) as a single oral dose 1 hour before treatment.
干预措施: Trypsin, Bromelain and Rutoside (Drug)
Placebo group
Patients will receive a single oral dose of placebo (opaque white capsule filled with starch) 1 hour before treatment
干预措施: Placebo (Other)
NSAIDs Group
Patients will receive Diclofenac Potassium (50 mg) as a single oral dose 1 hour before treatment.
干预措施: Diclofenac Potassium 50mg Tab (Drug)
结局指标
主要结局
Success of Anesthesia
时间窗: through study completion "an average of 1 year"
Success of Inferior alveolar Nerve block anesthesia will be measured by recording the patient's pain severity before and after anesthesia administration as well as during endodontic procedures. each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.
Post-operative pain
时间窗: through study completion "an average of 1 year"
postoperative pain as recorded by the patient after completion of treatment in on visit. patient will receive a pain diary to record their postoperative pain incidence and severity at 6, 12, 24, 72 hours and 7 days after endodontic treatment. Each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.
次要结局
未报告次要终点