The Effect of Diclofenac Potassium Insitu Gel Versus Calcium Hydroxide as Intra-canal Medications on Post-operative Pain and Anti-bacterial Effect in Lower Non Vital Premolars With Symptomatic Apical Periodontitis
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Incidence of Post operative pain assessed by VAS
研究概览
简要总结
The aim of this study is to clinically compare the post-operative pain level and antibacterial effect when using the Diclofenac Potassium Insitu gel versus calcium hydroxide as an intra- canal medication in patients with apical periodontitis.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-45 years old.
- •Males/Females.
- •Lower permanent premolars with: Non-Vital pulps. Sensitive to percussion. Negative response to cold pulp tester (ethyl chloride spray1). Apical periodontitis
- •Systemically healthy patients (ASA I or 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.
- •Teeth with :
- •Association with swelling or fistulous tract.
- •Acute or chronic peri-apical abscess. Mobility Grade II or III.
- •Pocket depth more than 5mm.
- •Previous root canal therapy.
- •Non-restorability
- •Patients with a contraindication for the use of DFK or those known to be allergic to any of the study medications.eg. Patient with kidney problems.
研究组 & 干预措施
Diclofenac Potassium
In the form of insitu gel can be applied as solution or suspension that undergoes gelation after administration.
干预措施: Diclofenac Potassium (Drug)
Calcium Hydroxide
干预措施: Diclofenac Potassium (Drug)
结局指标
主要结局
Incidence of Post operative pain assessed by VAS
时间窗: 72 hours
Post-operative pain following chemo-mechanical endodontic treatment will be measured. A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: * 0, "no pain" * 1-3, "mild pain" * 4-6, "moderate pain" * 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.
次要结局
- Antibacterial effectiveness by measuring the bacterial count.(pre-operatively(S1), after chemo-mechanical preparation(S2), and after 1 week(S3).)
研究者
Salma Mohamed Aboul Azayem
Prinicipal Investegator
Cairo University