Comparison of Antimicrobial Action of Sodium Hypochlorite and Polyhexamethylene Biguanide as Root Canal Irrigants in Patients Reporting With Non-vital Necrotic Pulp and Apical Periodontitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bacterial load assessed by culture
研究概览
简要总结
The aim of this randomized clinical trial is to compare the antibacterial effects of sodium hypochlorite (NaOCl) and Polyhexamethylene biguanide during root canal treatment .
详细描述
This study will compare the antibacterial effectiveness of sodium hypochlorite and PHMB, to find out whether PHMB can be used as a substitute to NaOCL. Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity.
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
The microbiologist will be kept blind to avoid risk of bias.
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
- •• Patients aged 18 to 50 years
- •Both male and female patients
- •Periodontally healthy teeth as determined by Periodontal Probing
- •Patients with non-vital necrotic pulps as determined by Cold Test
- •Patients with acute apical periodontitis determined by history and clinical examination
- •Clinical Findings:
- •Visual: Carious tooth decay Occlusion: Hyperocclusion Pulp vitality test: Negative Periapical radiograph: Caries involving pulp space and PDL widening Percussion Test: Positive Palpation Test: Negative
- •Single rooted teeth as determined radiographically
排除标准
- •• Multirooted teeth
- •Teeth undergoing Re-endo treatments
- •Teeth with root fractures and/ non restorable determined by clinical and radiographic examination
- •Patients receiving antibiotic treatment in the past 3 months determined by history
- •Patient with Diabetes determined by history
- •Patient with history of smoking
研究组 & 干预措施
Polyhexamethylene biguanide
Polyhexamethylene biguanide (PHMB), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. It is non-corrosive, non-toxic and acts by disrupting cell membrane integrity. PHMB 0.2% has been recently used as a root canal irrigant in vitro and has shown promising results of antimicrobial effectiveness of > 99.9% for both PHMB and Sodium hypochlorite
干预措施: Polyhexamethylene biguanide (Drug)
Sodium Hypochloride
A number of irrigant solution has thus been proposed to serve the purpose, the most popular being sodium hypochlorite (NaOCl) because of its excellent antimicrobial activity but also the ability to dissolve organic matter.
干预措施: Sodium Hypochlorite (Drug)
结局指标
主要结局
Bacterial load assessed by culture
时间窗: 24 hours
Effectiveness of irrigant will be evaluated with the existence or non-existence of bacteria: Positive Effect = no bacteria exist, Negative Effect = bacteria exist. Bacterial analysis will be performed by counting the number of colonies of bacteria in the specimen: No growth = no colonies seen, Few growths = less than 10 colonies of bacteria seen, Moderate growth = less than 100 colonies more than 10 colonies of bacteria seen, Heavy growth = more than 100 colonies of bacteria seen.
次要结局
未报告次要终点
研究者
Hira Abbasi
Principal Investigator
Altamash Institute of Dental Medicine