Post-operative Pain Following Different Irrigation Activation and Disinfection Approaches in Single-rooted Teeth With Asymptomatic Apical Periodontitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Post-operative pain intensity
研究概览
简要总结
This randomized clinical trial aimed to evaluate post-operative pain (PP) in single-rooted teeth with asymptomatic apical periodontitis following final irrigation with sonic activation systems (EDDY and EndoActivator), with and without adjunctive 980-nm diode laser disinfection. Eighty patients were randomized into four groups: Group 1 (EDDY), Group 2 (EndoActivator), Group 3 (EDDY + laser), and Group 4 (EndoActivator + laser). PP intensity and analgesic intake were recorded at 8, 24, 48 hours, and on day 7. The study found no significant differences in PP or analgesic use among the groups, indicating that laser-assisted or different sonic activation methods did not reduce post-operative pain.
详细描述
Post-operative pain (PP) is a common concern following root canal treatment, influenced by mechanical, chemical, and microbial factors. Effective irrigation and disinfection are crucial to remove debris and microorganisms from complex canal systems. This study investigated the effects of two sonic irrigation activation systems, EDDY and EndoActivator (EA), with and without 980-nm diode laser disinfection, on PP in patients with single-rooted teeth diagnosed with asymptomatic apical periodontitis.
Eighty medically healthy adult patients (18-65 years) were randomly assigned to four groups. Group 1 underwent final irrigation with EDDY; Group 2 with EA; Group 3 with EDDY followed by laser irradiation; Group 4 with EA followed by laser irradiation. All procedures were completed in a single visit. PP was measured using a 0-10 numerical rating scale at 8, 24, 48 hours, and day 7. Analgesic consumption was also recorded.
Statistical analysis showed no significant differences among groups for age, sex, PP scores, or analgesic intake. None of the patients experienced severe pain or swelling requiring emergency intervention. The findings suggest that both EDDY and EA sonic irrigation systems, with or without adjunctive 980-nm diode laser disinfection, do not significantly affect post-operative pain or analgesic use following single-visit root canal treatment of asymptomatic apical periodontitis.
These results provide insight into the effectiveness of sonic irrigation activation and laser disinfection in routine endodontic practice, indicating that alternative techniques may be explored to optimize patient comfort and treatment outcomes.
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 (Participant)
盲法说明
Patients were blinded to the irrigation and disinfection method. The operator was not blinded due to the nature of the interventions. Post-operative pain was self-reported by patients using numerical rating scales and outcomes assesor was was not blinded to group allocation.
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
- 是
入选标准
- •Medically healthy adult patients aged 18-65 years
- •Patients diagnosed with asymptomatic apical periodontitis in permanent single-rooted teeth with closed apices and radiographic PAI score of 3 or 4
- •Healthy periodontal conditions
排除标准
- •Pregnant women
- •Patients with systemic disorders
- •Teeth with open apex, prosthetic restorations, mobility > grade I, periodontal pocket depth > 4 mm, non-restorable condition, calcified root canals, resorption, traumatic occlusion, or history of previous endodontic treatment
- •Patients who had taken analgesics within 12 hours prior to intervention
- •Patients who had received antibiotic therapy within the past month
研究组 & 干预措施
EDDY sonic irrigation
Final irrigation activation was performed using the EDDY sonic system with 5.25% NaOCl for three 20-second cycles, followed by 17% EDTA for 30 seconds and 5 mL saline. No laser irradiation was applied.
干预措施: EDDY sonic irrigation system (Device)
EndoActivator (EA) sonic irrigation
Final irrigation activation was performed using the EndoActivator (EA) medium tip with 5.25% NaOCl for three 20-second cycles, followed by 17% EDTA for 30 seconds and 5 mL saline. No laser irradiation was applied.
干预措施: EndoActivator (EA) sonic irrigation system (Device)
EDDY sonic irrigation + 980-nm diode laser
Final irrigation activation was performed using the EDDY sonic system as in Arm 1, followed by adjunctive 980-nm diode laser irradiation (1.2 W, 50 Hz, 12 J per cycle, 4 cycles, pulsed mode).
干预措施: EDDY sonic irrigation system (Device)
EDDY sonic irrigation + 980-nm diode laser
Final irrigation activation was performed using the EDDY sonic system as in Arm 1, followed by adjunctive 980-nm diode laser irradiation (1.2 W, 50 Hz, 12 J per cycle, 4 cycles, pulsed mode).
干预措施: 980-nm diode laser (Device)
EndoActivator (EA) sonic irrigation + 980-nm diode laser
Final irrigation activation was performed using the EndoActivator (EA) system as in Arm 2, followed by adjunctive 980-nm diode laser irradiation (1.2 W, 50 Hz, 12 J per cycle, 4 cycles, pulsed mode).
干预措施: EndoActivator (EA) sonic irrigation system (Device)
EndoActivator (EA) sonic irrigation + 980-nm diode laser
Final irrigation activation was performed using the EndoActivator (EA) system as in Arm 2, followed by adjunctive 980-nm diode laser irradiation (1.2 W, 50 Hz, 12 J per cycle, 4 cycles, pulsed mode).
干预措施: 980-nm diode laser (Device)
结局指标
主要结局
Post-operative pain intensity
时间窗: 8, 24, and 48 hours, and 7 days after the endodontic procedure
Pain intensity was self-reported by patients using a numerical rating scale (0-10), where 0 indicates no pain and 10 indicates the worst possible pain.
次要结局
- Analgesic consumption(8, 24, and 48 hours, and 7 days after the endodontic procedure)
研究者
Sema Sönmez Kaplan
Associate Professor
Biruni University