Influence of Maintaining Apical Patency in Post-Endodontic Pain in Molars With Necrotic Pulp and Apical Periodontitis: 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
- 48
- 主要终点
- Post-operative Pain Intensity
研究概览
简要总结
This randomized controlled trial will investigate if maintaining apical patency-a technique where a small file is gently moved past the root's end during cleaning-affects pain after a root canal. The study will include 48 adult patients needing root canal treatment on a back molar tooth with a dead nerve and infection at the root tip. Participants will be randomly assigned to one of two groups: one where the apical patency technique is used, and one where it is not. All other treatment steps will be identical. Patients will record their pain levels on a standard scale (0-100 mm Visual Analog Scale) at 6, 12, 24, 48, and 72 hours after the procedure. The goal is to determine if this specific technique influences the intensity and duration of post-treatment pain
详细描述
BACKGROUND: Post-operative pain remains a significant challenge in endodontics, impacting patient satisfaction. The clinical practice of maintaining apical patency-passively keeping the apical foramen patent with a small file-is debated, with conflicting evidence on its impact on post-endodontic pain. This study aims to provide clear evidence from a robust randomized controlled trial.
OBJECTIVE: To determine the influence of maintaining apical patency on the intensity and duration of post-endodontic pain in molars with necrotic pulp and apical periodontitis.
METHODS:
Study Design: Single-center, randomized, controlled, parallel-group trial.
Setting: Department of Operative Dentistry, Saidu College of Dentistry, Swat.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Adult patients aged 18-65 years.
- •Medically healthy, classified as American Society of Anesthesiologists (ASA) Physical Status I or II.
- •Presence of a single permanent molar tooth diagnosed with necrotic pulp and symptomatic apical periodontitis, and indicated for primary root canal treatment.
- •Patients who provide informed written consent to participate in the study. -
排除标准
- •Teeth with prior endodontic treatment or complex anatomy (e.g., calcified canals, severe curvature).
- •Patients with significant systemic illness (e.g., uncontrolled diabetes, immunocompromised status) or pregnancy.
- •History of analgesic intake within 72 hours prior to the root canal procedure.
- •Non-restorable teeth, teeth with severe periodontal disease (pocket depth >5mm), or teeth with root fractures.
- •Exclusion Criteria:
研究组 & 干预措施
Patency Group
: A #10 K-file is passively advanced 1.0 mm beyond the major apical foramen before and after each successive instrumentation size to maintain patency.
干预措施: Patency Group (Procedure)
Patency Group
: A #10 K-file is passively advanced 1.0 mm beyond the major apical foramen before and after each successive instrumentation size to maintain patency.
干预措施: Standard Root Canal Instrumentation (Procedure)
Non-Patency Group
Participants in this group will receive standard root canal treatment where instruments are carefully confined to the root canal space and do not proceed beyond the apical foramen. All other aspects of the treatment are identical to the Experimental arm.
干预措施: Standard Root Canal Instrumentation (Procedure)
Non-Patency Group
Participants in this group will receive standard root canal treatment where instruments are carefully confined to the root canal space and do not proceed beyond the apical foramen. All other aspects of the treatment are identical to the Experimental arm.
干预措施: Patency Group (Procedure)
结局指标
主要结局
Post-operative Pain Intensity
时间窗: 6 hours after the completion of the root canal procedure
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Post-operative Pain Intensity
时间窗: 12 hours after the completion of the root canal procedure
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Post-operative Pain Intensity
时间窗: 24 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Post-operative Pain Intensity at 6 hours
时间窗: 6 hours after the completion of the root canal procedure.
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Post-operative Pain Intensity at 12 hours
时间窗: 12 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
Post-operative Pain Intensity at 48 hours
时间窗: 48 hours
Pain level measured using a 100-mm Visual Analog Scale (VAS). Patients self-report by marking a line on a 100-mm horizontal scale, where 0 mm = "no pain" and 100 mm = "worst imaginable pain". The score is the distance in mm from the left anchor.
次要结局
- ncidence of Post-operative Pain Severity(Assessed at 6, 12, 24, 48, and 72 hours after the procedure)
- ncidence of Post-operative Pain Severity(Assessed at 6, 12, 24, 48, and 72 hours after the procedure. The data from all time points will be aggregated to compare the overall distribution of pain severity between groups.)
研究者
Faiz ur rahman
post graduate trainee
College of Physicians and Surgeons Pakistan