Effect of Simvastatin Versus Calcium Hydroxide Used as Intracanal Medicaments on Post-operative Pain and Total Amount of IL-6 and IL-8 in Periapical Fluids in Patients With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Post operative pain incidence and intensity assessed with numerical rating scale
研究概览
简要总结
Comparing the effect of Simvastatin versus calcium hydroxide used as an intracanal medicament on Post-operative Pain and Total amount of IL-6 and IL-8 in Periapical Fluids of lower premolars in patients with Symptomatic Apical Periodontitis:
详细描述
Lower premolars with symptomatic apical periodontitis will be selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using simvastatin or calcium hydroxide intracanal medication for 1 week. The endodontic treatment will be completed in two visits. Postoperative pain will be assessed using the Numerical Rating scale at 6, 12, 24, 48 hours post-instrumentation and at 6, 12, 24, 48 hours post-obturation. Periapical fluid sample will be collected immediately post-instrumentation and 1 week later pre-obturation. The periapical samples will be analyzed for total amounts of IL-6 and IL-8.
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
- Double (Participant, Outcomes Assessor)
盲法说明
After the participant is confirmed eligible for the study, the participant will drag an envelope and will be given a number. Based on this number the patient will be allocated to either intervention or control group after contacting the co- supervisor to reveal the assigned group of the current patient according to the generated random sequence.
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- •Lower single rooted premolars:
- •Presence of pain with percussion.
- •Widening in the periodontal membrane space or with small sized periapical radiolucency.
- •Diagnosed clinically with symptomatic apical periodontitis.
- •Patients' acceptance to participate in the trial.
- •Patients who can understand pain scale and can sign the informed consent
排除标准
- •Medically compromised patients
- •Pregnant women
- •Patients who are allergic to non-steroidal anti-inflammatory drugs.
- •Patients with two or more adjacent teeth requiring root canal therapy
- •If analgesics or antibiotics have been administrated by the patient during the past two weeks preoperatively.
- •Patients reporting bruxism or clenching.
- •Teeth associated with acute periapical abscess, swelling or a fistulous tract.
- •Greater than grade I mobility or pocket depth greater than 5mm.
- •Non restorable teeth.
- •Immature teeth.
- •Teeth with previous endodontic treatment.
- •Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
研究组 & 干预措施
Simvastatin
Simvastatin as an intracanal medication
干预措施: Simvastatin Powder (Drug)
Calcium hydroxide
Calcium hydroxide intracanal medication
干预措施: Calcium Hydroxide (Drug)
结局指标
主要结局
Post operative pain incidence and intensity assessed with numerical rating scale
时间窗: 6,12,24 and 48 hours post-instrumentation and 6,12,24 and 48 hours post-obturation
0 (none) to 10 (severe) Numerical Pain Rating Scale
次要结局
- Total amount of IL-6 and IL-8 in periapical fluids(Immediately post-instrumentation and pre-obturation (1 week post- instrumentation))
研究者
Mohammed Essam Othman Ibrahim
Assisstant lecturer
Cairo University