Clinical Trial

Comparative Evaluation of Pediatric Rotary Files and Hand Files in Primary Molars

Completed
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to evaluate and compare the efficacy of Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files for biomechanical preparation during pulpectomy of primary mandibular molars in children aged 5-8 years. The main questions it aims to answer are: * Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems result in better obturation quality compared with manual K-files during pulpectomy of primary mandibular molars? * Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems reduce postoperative pain compared with manual K-files following pulpectomy? Researchers will compare Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files to determine their effect on obturation quality and postoperative pain. Participants will: * Undergo clinical and radiographic evaluation of primary mandibular molars requiring pulpectomy. * Be randomly allocated to one of three instrumentation groups: Kedo-Nano Plus rotary files, Kedo-S Square rotary files, or manual K-files. * Receive pulpectomy treatment using the assigned instrumentation technique. * Undergo radiographic assessment of obturation quality following treatment. * Have postoperative pain assessed using the Wong-Baker Faces Pain Rating Scale at 6, 12, 24, and 48 hours after treatment.
Trial Details
NCT Number NCT07702877
Lead Sponsor Goa Dental College
Conditions Pulpectomy, Primary Teeth Indicated for Pulp Therapy, Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
Enrollment 60 participants
Start Date 2025-01-15
Primary Completion 2026-01-02 (estimated)
Study Completion 2026-03-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-14