Comparison of Postoperative Pain Using 2% Chlorhexidine Versus 5.25% Sodium Hypochlorite as Root Canal Irrigants in Non-surgical Root Canal Treatment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Postoperative pain intensity at 24 hours
研究概览
简要总结
Brief Summary (A short description for the lay public)
This study aims to find out if the type of cleaning solution used during a root canal affects the pain a patient feels the next day. A root canal procedure involves cleaning the inside of the tooth. Two common cleaning solutions are chlorhexidine (CHX) and sodium hypochlorite (NaOCl, also known as bleach). While both are effective, it is not clear if one causes more discomfort than the other.
In this research, half of the participants will have their root canal cleaned with CHX, and the other half with NaOCl. We will then ask all participants to rate their pain 24 hours after the procedure using a simple pain scale. Our goal is to see if there is a difference in pain levels between the two groups. The results will help dentists choose the best solution to make their patients more comfortable after treatment
详细描述
Detailed Description (Extended technical description of the protocol)
This study is designed as a randomized controlled trial to compare the intensity of postoperative pain 24 hours after non-surgical root canal treatment using two different irrigating solutions: 2% chlorhexidine (CHX) and 5.25% sodium hypochlorite (NaOCl). The central hypothesis is that the type of irrigant influences early postoperative pain, but that this effect may be modified by patient-specific factors such as gender and age.
Methodology:
Following ethical approval and informed consent, 90 adult patients indicated for non-surgical root canal treatment will be enrolled using a non-probability consecutive sampling technique. Participants will be randomly allocated to one of two parallel groups (n=45 per group): Group A (2% CHX) and Group B (5.25% NaOCl). The sample size was calculated a priori using the pwr package in R, assuming a 95% confidence level, 80% power, and a moderate effect size based on previous studies.
A standardized endodontic protocol will be followed for all participants to ensure consistency and minimize bias:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years
- •Any gender
- •Requiring non-surgical root canal treatment
- •Willing to provide written informed consent
- •Able to report postoperative pain using a validated pain assessment scale -
排除标准
- •Known hypersensitivity or allergy to chlorhexidine or sodium hypochlorite
- •Systemic conditions affecting pain perception (e.g., diabetes with neuropathy, fibromyalgia)
- •Medications affecting pain perception (e.g., chronic analgesics, corticosteroids, antidepressants)
- •Preoperative dental pain in the tooth scheduled for treatment
- •Pregnancy or lactation
- •Teeth with resorbed roots
- •Mobile teeth (pathological mobility)
- •Open apices
研究组 & 干预措施
2% Chlorhexidine Group
Root canal irrigation with 2% chlorhexidine gluconate solution. 2 mL after each instrument, 27-gauge side-vented needle, 1-2 mm short of working length, passive flow 2-4 mL/min.
干预措施: Chlorhexidine gluconate 2% (Procedure)
2% Chlorhexidine Group
Root canal irrigation with 2% chlorhexidine gluconate solution. 2 mL after each instrument, 27-gauge side-vented needle, 1-2 mm short of working length, passive flow 2-4 mL/min.
干预措施: Sodium hypochlorite 5.25% (Drug)
5.25% Sodium Hypochlorite Group
Root canal irrigation with 5.25% sodium hypochlorite solution. 2 mL after each instrument, 27-gauge side-vented needle, 1-2 mm short of working length, passive flow 2-4 mL/min.
干预措施: Chlorhexidine gluconate 2% (Procedure)
5.25% Sodium Hypochlorite Group
Root canal irrigation with 5.25% sodium hypochlorite solution. 2 mL after each instrument, 27-gauge side-vented needle, 1-2 mm short of working length, passive flow 2-4 mL/min.
干预措施: Sodium hypochlorite 5.25% (Drug)
结局指标
主要结局
Postoperative pain intensity at 24 hours
时间窗: 24 hours after root canal treatment completion
Pain intensity measured using a 4-point Visual Analog Scale (VAS): 0 = no pain, 1 = mild pain, 2 = moderate pain (required analgesics with relief), 3 = severe pain (analgesics no relief). Patient-reported 24 hours post-treatment.
次要结局
未报告次要终点
研究者
Faiz ur rahman
Postgraduate Resident, Department of Operative Dentistry
College of Physicians and Surgeons Pakistan