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临床试验/NCT07181252
NCT07181252已完成不适用

Comparison of Post-operative Pain in Relation to Working Length Assessment by Electronic Apex Locator and Digital Radiography in Permanent Teeth Among Pediatric Patients

Jouf University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
130
试验地点
1
主要终点
Pre- and post-operative pain assessment

研究概览

简要总结

This randomized, double-blind clinical trial was conducted at the College of Dentistry, Jouf University, Kingdom of Saudi Arabia, between August 2024 and February 2025. A total of 130 pediatric patients were recruited from the outpatient department.

详细描述

Sample Size and Participants The sample size was calculated based on a previous study by Guzel et al. [16], which assessed post-operative pain in relation to different working length determination methods. To detect a 10% difference in mean pain scores with 95% confidence and 80% power, a minimum sample of 124 participants was required. Accounting for a 5-10% attrition rate, the final sample size was increased to 130 (65 in each group).

Inclusion Criteria Children aged 10-15 years. Clinical and radiographic diagnosis of irreversible pulpitis. Absence of systemic disease. Permanent first molars with mature apices. No radiographic evidence of root resorption or periodontal bone loss. Written consent from a parent or legal guardian. Exclusion Criteria Medically compromised or psychologically unfit children. Teeth with periapical lesions on radiographs. Teeth with severely curved or calcified canals. Presence of acute or chronic systemic inflammatory conditions. Randomization and Blinding

Participants were randomly allocated into two groups using the coin-flip method:

EAL group: Working length determination using EAL DR group: Working length determination using DR The participants and the investigator of post-operative pain were blinded to the group allocation. All clinical procedures were carried out by a single experienced endodontist who was not involved in pain assessment.

Clinical Procedure All root canal treatments were completed in a single visit under local anesthesia using 2% lignocaine with 1:80,000 epinephrine. Caries excavation and access cavity preparation were performed using sterilized high- and low-speed burs. Patency was confirmed using a #10 K-file.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 10-15 years. Clinical and radiographic diagnosis of irreversible pulpitis. Absence of systemic disease. Permanent first molars with mature apices. No radiographic evidence of root resorption or periodontal bone loss. Written consent from a parent or legal guardian.

排除标准

  • Medically compromised or psychologically unfit children. Teeth with periapical lesions on radiographs. Teeth with severely curved or calcified canals. Presence of acute or chronic systemic inflammatory conditions.

结局指标

主要结局

Pre- and post-operative pain assessment

时间窗: 1 year

Pain was evaluated using a 10-point Visual Analog Scale (VAS), where 0 indicated "no pain" and 10 denoted "worst possible pain." Participants were trained to use the scale pre-operatively and were provided with printed forms to record pain at specific post-operative intervals: 6 hours, 12 hours, 24 hours, 48 hours, and 7 days. Pre-operative pain scores were recorded before starting the procedure. This method has been widely used in pediatric endodontic research for subjective pain evaluation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rakhi Issrani

Lecturer

Jouf University

研究点 (1)

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