Evaluation of Post-operative Pain and Bacterial Load Reduction After Application of Different Final Irrigation Protocols in Single Visit Root Canal Treatment of Mandibular First Molar Teeth With Symptomatic Irreversible Pulpitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post-operative pain after each activation method in comparison to control group
研究概览
简要总结
The primary objective of root canal treatment is to clean, disinfect, and hermetically seal the root canal system to prevent bacterial penetration; however, postoperative pain is frequently encountered, particularly in patients with symptomatic irreversible pulpitis. This condition, defined by the American Association of Endodontists as an irreversible inflammatory state of the pulp, is commonly associated with spontaneous pain, lingering discomfort, and heightened thermal sensitivity, and often represents a significant challenge in endodontics. Postoperative pain is usually linked to extrusion of microorganisms and debris into the periapical region during chemo-mechanical preparation. Bacteria remain the most persistent pathogens in root canal infections, and although sodium hypochlorite (NaOCl) is considered the most effective irrigant due to its antibacterial and tissue-dissolving properties, complete bacterial elimination before root filling is not always achieved. To enhance its antimicrobial efficacy, various adjunctive approaches have been suggested, including passive ultrasonic activation (PUA) and modifying NaOCl temperature, either by heating or cooling. Cryotherapy has gained increasing attention in endodontics for its potential to decrease postoperative pain and bacterial load, with additional reported benefits in vital pulp therapy, instrumentation, and anesthesia. Previous studies have shown that cryo-irrigation after NaOCl significantly reduces bacterial counts compared to NaOCl alone. Considering the potential benefits of these different irrigation protocols, the present study aims to evaluate and compare their effectiveness in reducing postoperative pain and bacterial load following single-visit root canal treatment of mandibular first molars diagnosed with symptomatic irreversible pulpitis.
The aim of the study will be directed to evaluate postoperative pain and bacterial load reduction after application of different final irrigation protocols in single visit root canal treatment in patients with symptomatic irreversible pulpitis in first molar teeth. this study consists of 60 patients divided into 4 groups each group having 15 patients.
control: Final irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min interventions: I1: Final irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min . I2: Final irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min. I3:Final irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min
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
- 18 Years 至 40 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with age range between 18 to
- •No sex predilection.
- •Patients with symptomatic irreversible pulpitis.
- •Patients able to sign informed consent.
- •Restorable teeth
- •Positive patient's acceptance for participating in the study.
- •Type III distal and mesial canal of first mandibular molar.
- •Mild to moderate (5-20) ° curvature according to Schneider
排除标准
- •Pregnant females
- •Medically compromised patients.
- •Patients having analgesics before the treatment
- •If antibiotic have been administrated during the past two weeks preoperatively.
- •Patients having bruxism or clenching
- •Patients having sever malocclusion associated with traumatic occlusion.
- •Teeth that have:
- •Peri-apical periodontitis Root resorption Pain on percussion Pulp stones or calcifications Previous endodontic treatment.
- •Non-patent canals
研究组 & 干预措施
Final irrigation by NaOcl at room temperature
Final irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min.
干预措施: Final irrigation by NaOcl at room temperature (Procedure)
Final irrigation by cryotreated NaOcl.
Final irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min
干预措施: Final irrigation by cryotreated NaOcl. (Procedure)
Final irrigation by preheated NaOcl.
Final irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min
干预措施: Final irrigation by preheated NaOcl (Procedure)
Final irrigation with ultrasonic activation of NaOcl.
Final irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min
干预措施: Final irrigation with ultrasonic activation of NaOcl (Procedure)
结局指标
主要结局
Post-operative pain after each activation method in comparison to control group
时间窗: from 6 to 72 hours from the treatment .
measuring Post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical score: none (0): mild (1-3), severe (7-10).
次要结局
- bacterial load change after final irrigation protocol.("immediately after the intervention.)
研究者
Samar Tarek
principal investigator
Future University in Egypt
