Assessment of Postoperative Pain and Antibacterial Activity of Chitosan Nanoparticles Versus Sodium Hypochlorite as a Root Canal Irrigant in Infected Root Canal
试验速览
- 阶段
- 2 期
- 入组人数
- 24
- 主要终点
- antibacterial activity
研究概览
简要总结
A randomized clinical trial that aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal.
详细描述
This trial aims to study the effect of chitosan nanoparticles (CS-np) versus sodium hypochlorite as a root canal irrigant on postoperative pain and antibacterial activity against E.faecalis in infected root canal. initial pre-treatment root canal sample will be taken.These will be designated as sample no.1. after first sample, according to random sequence, the patients will be randomly assigned into two groups. In Group I: Sodium hypochlorite (NaOCL 2.5%) will be used during instrumentation of the canals.In Group II: chitosan nanoparticles (CS-np) will be used. after preparation, the sample no.2 will be taken.Pain will be assessed by giving the patient the numerical pain rating scale (NRS) to assess his pain at 24, 48 and 72 hours after the first 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)
盲法说明
Double blinded The patient is also outcome assessor will be blinded as well as data analyst person.
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
- •Young adult Patients, both genders, aging from 18-45 years.
- •Patients with permanent mature teeth (closed apex).
- •Single rooted single canal necrotic anterior teeth without apical periodontitis or with slight widening of peridontium.
- •Patients should be free from any systemic disease.
- •Patients with normal periodontal depth less or equal 3 mm.
- •Patients who will agree to the consent and will commit to follow-up.
排除标准
- •Patients with permanent immature teeth.
- •Teeth with vital pulps.
- •Patients with facial swelling or acute infection or pain on percussion
- •Patients with fistula.
- •Teeth with vertical root fractures, internal or external root resorption and calcification
- •Teeth with periodontal involvement or periapical bone loss.
- •Patients with any systemic disease that may affect predictable outcome.
- •Pregnant or lactating females.
- •Non-restorable teeth.
研究组 & 干预措施
sodium hypochlorite
Sodium hypochlorite (NaOCL) is the most recommended irrigant due to its broad antibacterial effect, necrotic tissues and dentin collagen dissolving capability and inactivation of endotoxins.10ml of 2.5%NaOCL will be used during instrumentation in control group
干预措施: Sodium Hypochlorite (Drug)
chitosan nanoparticles
Chitosan is a bioactive polymer obtained from deacetylation of chitin and is used in biomedical application due to its antimicrobial properties and biocompatibility and ability to resist aging for longer periods provide antibacterial effect in root canal disinfection.10ml of cs-np will be used during instrumentation in intervention group
干预措施: chitosan nanoparticles (Drug)
结局指标
主要结局
antibacterial activity
时间窗: two samples will be taken at the same visit of endodontic treatment at day 1, the outcome measures will be assessed after 24h. the data will be reported after study compeletion about 1 year
antibacterial activity will be evaluated by Sampling and culture method. The samples will be subjected to microbiological analysis to ascertain their individual microbiological load after 24h, this will be analyzed by counting the colony forming units (CFUs).
次要结局
未报告次要终点