Effect Of Propolis Nanoparticles Versus Sodium Hypochlorite As Root Canal Irrigant On Postoperative Pain And Bacterial Reduction In Mandibular Premolars With Necrotic Pulps (A Randomized Clinical Trial)
试验速览
- 阶段
- 2 期
- 入组人数
- 44
- 主要终点
- Postoperative pain
研究概览
简要总结
The aim of this study is to clinically compare the intensity of post-operative pain and the amount of bacterial reduction after using 20mg/ml propolis nanoparticles extract solution during chemo-mechanical preparation, versus 2.5% NaOCl, in asymptomatic necrotic mandibular premolars treated in a single visit.
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)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systematically healthy patient (ASA I,II).
- •Age between 20 and 55 years
- •Male or female.
- •Asymptomatic mandibular premolar teeth diagnosed with pulp necrosis with or without apical periodontitis.
- •Radiographic examination using Digora intraoral periapical sensor plate and software (Digora; Soredex, Helsinki, Finland) showing mandibular premolars with (smaller than 3 mm (0-2 mm)) periapical radiolucency.
排除标准
- •Medically compromised patients having significant systemic disorders. (ASA III or IV).
- •History of intolerance to NSAIDS.
- •Teeth with:
- •Immature roots
- •Vital pulp tissues.
- •Association with swelling.
- •Acute peri-apical abscess or acute exacerbation of a chronic abscess.
- •Mobility Grade II or III.
- •Previously accessed or endodontically treated
- •Deep periodontal pockets more than 4 mm
- •Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
- •Patients who could not interpret the NRS.
- •Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.
研究组 & 干预措施
Propolis nanoparticles extract solution
干预措施: Propolis nanoparticles extract solution (Dietary Supplement)
sodium hypochlorite
干预措施: sodium hypochlorite (Drug)
结局指标
主要结局
Postoperative pain
时间窗: up to 48 hours postoperatively
postoperative pain will be marked by the patient using the Numerical rating scale (NRS) chart which is an 11 point scale consisting of numbers from 0 through 10, where: 0: reading represents "no pain" 1-3: readings represent "mild pain" 4-6: readings represent "moderate pain" 7-10: readings represent "severe pain"
次要结局
- Intracanal bacterial load change(Throughout the chemo-mechanical preparation of the canal.)
- Number of analgesic tablets taken by the patient after endodontic treatment(Up to 48 hours postoperative.)
研究者
Radwa Mohamed Saleh Elaguizy
Principal Investigator (Endodontic Resident)
Cairo University