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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Facial Expressions; Root Canal Treatment in Children Primary Molars; Facial Emotions; Artificial Intelligence Mobile Application; Sonic Activation
• Intervention / Treatment: Procedure: Root canal treatment in primary molars with irreversible pulpitis; Device: EDDY system for sonic activation of irrigation; Device: side-vented needle

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ismailia, Egypt
    • Faculty of Dentistry Suez Canal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Children's age range 5-8 years. Boys and girls will be included.
2. Children with positive or definitely positive behavior on the Frankl's behavior rating scale (rating 3 or 4 on the scale).
3. Children with at least one primary molar with irreversible pulpitis and symptomatic apical periodontitis confirmed using periapical radiographs, percussion, and cold test.
4. Children having teeth with two-thirds of each root remaining.
5. 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.
6. Children with no allergy to Ibuprofen.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sonic activation of irrigation; Sonic activation of irrigation with Eddy system	Procedure: Root canal treatment in primary molars with irreversible pulpitis; Root canal treatment in primary molars with irreversible pulpitis followed by coronal restoration with stainless-steel crowns in a single visit.; Device: EDDY system for sonic activation of irrigation; sonic activation of irrigation with EDDY system during root canal treatment in primary molars
Placebo Comparator: No activation; Irrigation with side-vented needle without activation	Procedure: Root canal treatment in primary molars with irreversible pulpitis; Root canal treatment in primary molars with irreversible pulpitis followed by coronal restoration with stainless-steel crowns in a single visit.; Device: side-vented needle; conventional irrigation with side-vented needle without activation during root canal treatment in primary molars

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five-Face Pain Scale Score	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)	8 ,24,48,72 hours, and after 1week post-operative
facial expressions analysis	facial expressions of the patients are assessed from their photographs and analyzed by the AI Emotion Detector mobile application. Unit of Measure: Percentage (%)	8 ,24,48,72 hours, and after 1week post-operative

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Study Chair: Ghada Abdelhamid El-Baz, Professor of Pedodontics, Faculty of dentisrty, Suez Canal University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: August 2, 2025
• First Submitted That Met QC Criteria: August 16, 2025
• First Posted (Actual): August 24, 2025

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Facial emotions; Postoperative pain; Primary molars; AI applications; Sonic activation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Communication; Nonverbal Communication; Pain, Postoperative; Facial Expression
• Other Study ID Numbers: 728/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to patient confidentiality restrictions.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No