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

NCT07181252 | Completed DMC

• 1 other identifier: LCBE 24-03/41
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric; Radiography

Keywords

Digital radiography; Electronic apex locator; Dentistry

Outcome Measures

Primary Outcomes (1)

• Pre- and post-operative pain assessment

  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

  1 year

Study Arms (2)

EAL group

Working length determination using EAL

Diagnostic Test: Working length of root

DR group

Working length determination using DR

Diagnostic Test: Working length of root

Interventions

Working length of root DIAGNOSTIC_TEST

EAL Group: Working length was measured using the Root ZX apex locator (J. Morita Corp., Kyoto, Japan), following the manufacturer's instructions. A #15 K-file was connected to the device and advanced until the display indicated "APEX," confirming the location beyond the apical foramen. DR Group: Working length was determined using a #15 K-file inserted 1 mm short of the estimated radiographic apex. A digital periapical radiograph was taken, and the working length was adjusted accordingly. Repeated radiographs were obtained until the file tip was 1 mm short of the radiographic apex.

DR group; EAL group

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jouf University: lead

Study Sites (1)

College of Dentistry, Jouf University

Sakakah, Al Jawf Region, 75432, Saudi Arabia

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: August 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

SA (1)