Antibacterial Efficacy and Outcomes of Root Canal Irrigation Methods
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Reduction in Total Intracanal Bacterial Load
研究概览
简要总结
This randomized clinical trial aims to evaluate the antibacterial efficacy and treatment outcomes of three different final irrigation protocols during root canal therapy: 2.5% sodium hypochlorite alone, sodium hypochlorite with Passive Ultrasonic Irrigation (PUI), and sodium hypochlorite with XP-Endo Finisher activation. Sixty-six single-rooted teeth with pulp necrosis and apical periodontitis will be randomly assigned to one of the three groups. Antibacterial efficacy will be assessed through Real-Time PCR quantification of total bacterial load and four specific bacterial species before and after treatment. Treatment success will be evaluated clinically and radiographically at 6 and 12 months. The study aims to identify the most effective irrigation strategy for bacterial reduction and healing outcomes.
详细描述
This randomized, two-arm, parallel clinical trial investigates the antibacterial effectiveness and clinical outcomes of three root canal final irrigation protocols in teeth with pulp necrosis and apical periodontitis. Following standard chemomechanical preparation, participants' teeth will be randomly assigned to one of three interventions: final irrigation with 2.5% sodium hypochlorite alone, sodium hypochlorite activated by Passive Ultrasonic Irrigation (PUI) or sodium hypochlorite activated with the XP-Endo Finisher file.
The study focuses on the reduction of total bacterial load and specific pathogenic bacterial species (Pseudoramibacter alactolyticus, Treponema denticola, Streptococcus anginosus, and Porphyromonas endodontalis ) assessed through highly sensitive quantitative Real-Time PCR analysis of samples collected at different treatment stages. Sampling procedures ensure strict aseptic conditions and standardized protocols for DNA extraction and analysis.
All participants will undergo a standardized endodontic treatment protocol by a single operator to minimize variability. Follow-up includes clinical and radiographic examinations at 6 and 12 months, with healing assessed through the Periapical Index (PAI) and presence or absence of clinical symptoms.
This trial aims to provide new clinical evidence regarding the added value of supplementary irrigation techniques, comparing their ability to reduce bacterial burden and influence long-term treatment success.
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)
盲法说明
The operator performing the procedure is not blinded, but outcome assessors evaluating healing at follow-up could be blinded
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent by the patients who wish to participate in the study.
- •Single-rooted teeth with pulp necrosis confirmed by pulp sensibility tests, negative response to both cold and electric pulp testing and radiographic evidence of apical periodontitis.
- •Teeth with relatively straight canals, complete root development and no radiographic evidence of pulp canal obliteration.
排除标准
- •Patients who have received antibiotic treatment the last 3 months or need chemoprophylaxis for dental treatment.
- •Teeth with previous endodontic treatment.
- •Teeth with cracks or incomplete vertical root fracture which disturbs the integrity of the pulp chamber walls or teeth with the pulp chamber exposed to oral environment.
- •Teeth with periodontal pocket more than 4mm.
研究组 & 干预措施
Final Irrigation with 2.5% Sodium Hypochlorite
Root canals will be irrigated with 2.5% sodium hypochlorite as the final irrigation without activation.
干预措施: Final Irrigation with 2.5% Sodium Hypochlorite (Procedure)
Passive Ultrasonic Irrigation with NaOCl
Root canals will be irrigated with 2.5% sodium hypochlorite activated by Passive Ultrasonic Irrigation (PUI).
干预措施: Passive Ultrasonic Irrigation (PUI) with Sodium Hypochlorite (Procedure)
XP-Endo Finisher activation with NaOCl
Root canals will be irrigated with 2.5% sodium hypochlorite followed by mechanical activation using the XP-Endo Finisher file.
干预措施: XP-Endo Finisher Activation with Sodium Hypochlorite (Procedure)
结局指标
主要结局
Reduction in Total Intracanal Bacterial Load
时间窗: 0ne to six months
Quantitative reduction of the total intra canal bacterial load measured by Real-Time PCR (qPCR) after final irrigation procedures.
次要结局
- Reduction in Specific Bacterial Species(one to six months)
- Clinical and Radiographic Healing Outcome(6 months and 12 months after root canal treatment)
研究者
Giorgos Tzanetakis
Associate Professor
National and Kapodistrian University of Athens