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临床试验/NCT07138937
NCT07138937已完成不适用

Efficiency of Sonic Activation During Root Canal Treatment of Primary Molars on Postoperative Pain and Facial Expressions of Children Using Artificial Intelligence

Suez Canal University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Five-Face Pain Scale Score

研究概览

简要总结

This study was conducted to evaluate the efficiency of sonic activation of 5%sodium hypochlorite during root canal treatment of primary molars on postoperative pain and facial expressions. In addition to comparing between the Five-face pain scale and AI Emotion Detector mobile application in postoperative pain assessment.

详细描述

The current study addresses an important gap in research, as the impact of sonic activation of irrigation on postoperative pain in children and the validity of artificial intelligence mobile application in detecting facial expressions following root canal treatment as not been well explored.

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)

入排标准

年龄范围
5 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children's age range 5-8 years. Boys and girls will be included.
  • •Children with positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the scale).
  • •Children with at least one primary molar with irreversible pulpitis and symptomatic apical periodontitis confirmed using periapical radiographs, percussion, and cold test.
  • •Children having teeth with two-thirds of each root remaining.
  • •Children with a moderate to very severe (2-4) pain score according to five-face pain scale in only one tooth within the 24-h period before the procedure.
  • •Children with no allergy to Ibuprofen.

排除标准

  • •Teeth with pathological root resorption.
  • •Teeth with mobility greater than 1st-degree mobility.
  • •Children who received analgesics and/or antibiotics in the last 12 h before root canal treatment

研究组 & 干预措施

Sonic activation of irrigation

Active Comparator

Sonic activation of irrigation with Eddy system

干预措施: Root canal treatment in primary molars with irreversible pulpitis (Procedure)

Sonic activation of irrigation

Active Comparator

Sonic activation of irrigation with Eddy system

干预措施: EDDY system for sonic activation of irrigation (Device)

No activation

Placebo Comparator

Irrigation with side-vented needle without activation

干预措施: Root canal treatment in primary molars with irreversible pulpitis (Procedure)

No activation

Placebo Comparator

Irrigation with side-vented needle without activation

干预措施: side-vented needle (Device)

结局指标

主要结局

Five-Face Pain Scale Score

时间窗: 8 ,24,48,72 hours, and after 1week post-operative

Postoperative pain is assessed using the Five-Face Pain Scale (range: 0 = no pain to 4= worst pain; lower scores indicate less pain). Unit of Measure: Scale units (0-4)

facial expressions analysis

时间窗: 8 ,24,48,72 hours, and after 1week post-operative

facial expressions of the patients are assessed from their photographs and analyzed by the AI Emotion Detector mobile application. Unit of Measure: Percentage (%)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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