"Postoperative Pain Following Laser-Assisted Root Canal Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial"
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Postoperative pain assessment
研究概览
简要总结
The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.
Forty-five patients are equally divided into 3 separate groups :
- Group A (Conventional): 2.5% NaOCL and 17% EDTA.
- Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
- Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient is given pain scale chart Numeric Rating Scale (NRS) to record his/her pain level before any endodontic treatment. All data will be collected, tabulated, summarized, and statistically analyzed.
详细描述
Postoperative pain is a common complication following conventional endodontic treatment. According to a systematic review, the frequency of endodontic postoperative pain is between 3% and 58% of patients.Postoperative pain is attributed to chemical, mechanical and microbiological factors.
Residual microorganisms remaining due to the complexity of the root canal system and the limited penetration capability of conventional irrigants are directly responsible for Post operative pain The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.
Forty-five patients are equally divided into 3 separate groups :
- Group A (Conventional): 2.5% NaOCL and 17% EDTA.
- Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
- Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient will be given pain scale chart (NRS scale) to record his/her pain level before any endodontic treatment. After disinfection, local anesthetic, tooth isolation, access cavity preparation and final obturation. Patients are asked to mark on a numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity at 6, 12, 24, 48, 72 hours, and 7 days after the procedure All data will be collected, tabulated, summarized, and statistically analyzed.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who had asymptomatic, single-rooted maxillary anterior teeth with necrotic pulp and periapical lesion with a periapical index score of 3 or 4
- •Patients complaining of no pain and without fistulous tract
- •Closed apex.
- •Acceptance to participate in the study.
排除标准
- •Antibiotic use within the last month, anti-inflammatory analgesic use within the last 5 d, systemic diseases or allergic reactions, calcified canals, root resorption, previous root canal treatment.
- •Periodontal diseases, presence of swelling or fistulous tract.
- •Vulnerable group including pregnant females, mentally or physically disabled individuals. - Technical difficulties during root canal treatment such as; curved roots, broken files, over instrumentation, overfilling or incomplete filling.
研究组 & 干预措施
Dual laser group (Er,Cr:YSGG/Diode)
干预措施: Dual laser group (Device)
Combined group (EDTA/Diode):
干预措施: Combined group (Combination Product)
Conventional group A
干预措施: Conventional group (Drug)
结局指标
主要结局
Postoperative pain assessment
时间窗: Measure changes in post-operative pain up to 7 days after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Postoperative pain assessment
时间窗: Measure changes in post-operative pain 6 hours after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Postoperative pain assessment
时间窗: Measure changes in post-operative pain 12 hours after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Postoperative pain assessment
时间窗: Measure changes in post-operative pain 24 hours after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Postoperative pain assessment
时间窗: Measure changes in post-operative pain 48 hours after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Postoperative pain assessment
时间窗: Measure changes in post-operative pain 72 hours after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
次要结局
未报告次要终点
研究者
Sara Zakaria Fahim
assistant lecturer
Future University in Egypt