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

NCT07138937 | Completed

• 1 other identifier: 728/2024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Root Canal Treatment in Children Primary Molars; Postoperative Pain; Facial Expressions; Facial Emotions; Artificial Intelligence Mobile Application; Sonic Activation

Keywords

Sonic activation; Postoperative pain; Primary molars; AI applications; Facial emotions

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sonic activation of irrigation

ACTIVE COMPARATOR

Sonic activation of irrigation with Eddy system

Procedure: Root canal treatment in primary molars with irreversible pulpitis; Device: EDDY system for sonic activation of irrigation

No activation

PLACEBO COMPARATOR

Irrigation with side-vented needle without activation

Procedure: Root canal treatment in primary molars with irreversible pulpitis; Device: side-vented needle

Interventions

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.

No activation; Sonic activation of irrigation

EDDY system for sonic activation of irrigation DEVICE

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

Sonic activation of irrigation

side-vented needle DEVICE

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

No activation

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Dentistry Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Facial Expression

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nonverbal Communication; Communication; Behavior

Study Officials

• Ghada Abdelhamid El-Baz, Professor of Pedodontics

  Faculty of dentisrty, Suez Canal University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A comparative, randomized, prospective clinical trial to evaluate the efficacy of sonic activation versus no activation by comparing the pain scale and facial expressions following root canal treatment in primary molars.

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 24, 2025
• Study Start: August 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)