Effect of Diclofenac Potassium Versus Prednisolone as a Premedication on Post-endodontic Pain and Pulpal Interleukin (IL)-8 Expression in Symptomatic Irreversible Pulpitis Cases: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 36
- 主要终点
- Change in the intensity of post-endodontic pain
研究概览
简要总结
To assess the effect of using diclofenac potassium versus prednisolone as a pre-medication compared to placebo on:
- Intensity of post-endodontic pain in patients with symptomatic irreversible pulpitis.
- Pulpal IL-8 expression.
- Incidence of post-endodontic pain in patients with symptomatic irreversible pulpitis.
详细描述
After confirming the diagnosis and making sure that the patient conforms to all eligibility criteria, the principal investigator will enroll the patient in the study.
- Patients will be asked to rate their pre-operative pain intensity (ie, before the commencement of any treatment [baseline score]; on the visual analogue scale "VAS"
- Enrolled patients will be randomly assigned into one of three groups:
Intervention Group 1 (Diclofenac Potassium): single, oral dose of 50 mg diclofenac potassium pre-medication (Cataflam; NOVARTIS Pharma, Basel, Switzerland) one hour before starting endodontic treatment.
Intervention Group 2 (Prednisolone): single, oral dose of 30 mg prednisolone (one and a half tablets Solupred oro 20 mg, ARE, Aventis Intercontinental, Paris, France) 30 min before starting endodontic treatment.
Control Group (Placebo): The patients assigned to this group will be given a placebo tablet (Starch, Bridgewater, NJ) one hour before starting 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)
盲法说明
In this proposed study, the participant, and the assessor will be blinded. The participants will be blinded to the study hypothesis as to which intervention is expected to be better.
The patients, who already do not know their treatment group, will assess the level of their post-endodontic pain.
- The laboratory technician at the microbiological department will not know the treatment group of the patients.
- The treatment groups will remain anonymous at the end of the study during assessment by the statistician.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-50 years.
- •Males and females.
- •American Society of Anesthesiologists class 1 or
- •Mandibular premolar teeth with:
- •Endodontic pulpal diagnosis of symptomatic irreversible pulpitis
- •Normal/slight widening in the periodontal membrane space (PMS).
- •Patients who had not taken any anti-inflammatory drugs the day of the root canal procedure unless they belong to one of the intervention groups.
- •Patients who accept to participate in the trial, understand the VAS, and can sign the informed consent
排除标准
- •Cases with acute peri-apical conditions (acute apical periodontitis/ acute apical abscess), pulpal necrosis, previously initiated therapy, or previously treated.
- •Teeth other than single-rooted teeth.
- •Radiographic evidence of external or internal root resorption vertical root fracture, perforation, or calcification.
- •Immature teeth.
- •Unrestorable teeth or teeth with severe periodontal disease.
- •Patients with a known allergy, sensitivity, or history of other adverse reactions to the medications administered.
- •Patients with a history of active peptic ulcer within the preceding 12 months, bleeding problems, anticoagulant use within the last month, or kidney disease.
- •Patients who took analgesics/ anti-inflammatory drugs (steroidal or non-steroidal) the day of endodontic treatment.
- •Pregnant or nursing females.
- •Patients who are unable to provide informed consent
研究组 & 干预措施
Prednisolone premedication
Single, oral dose of 30 mg prednisolone pre-medication 30 min before starting endodontic treatment.
干预措施: Prednisolone 30 mg (Drug)
Diclofenac potassium premedication
Single, oral dose of 50 mg diclofenac potassium pre-medication 1 hour before starting endodontic treatment.
干预措施: Diclofenac Potassium 50mg Tab (Drug)
Placebo
Placebo tablet 1 hour before starting endodontic treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the intensity of post-endodontic pain
时间窗: Immediately after treatment completion; and at 6, 12, 24, and 48 hours post-operatively
Pain intensity will be evaluated using visual analogue scale
次要结局
- Quantification of pulpal IL-8(During the procedure)
研究者
Ahmed Adel Abdullah Ali Soliman
Principal Investigator
Cairo University