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Completed

NCT Number: NCT07138937

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

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.

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Key information

Conditions

Root Canal Treatment in Children Primary Molars Artificial Intelligence Mobile Application Behavior Communication Facial Emotions Facial Expression Facial Expressions Neurologic Manifestations Nonverbal Communication Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Sonic Activation

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Suez Canal University

Ismailia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Root canal treatment in primary molars with irreversible pulpitis

Procedure

Root canal treatment in primary molars with irreversible pulpitis followed by coronal restoration with stainless-steel crowns in a single visit.

EDDY system for sonic activation of irrigation

Device

sonic activation of irrigation with EDDY system during root canal treatment in primary molars

side-vented needle

Device

conventional irrigation with side-vented needle without activation during root canal treatment in primary molars

Primary outcomes

  1. Five-Face Pain Scale Score

    Time frame: 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)

  2. facial expressions analysis

    Time frame: 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 (%)

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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