Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT07702877

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

Conditions: Pulpectomy, Primary Teeth Indicated for Pulp Therapy, Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis

Sex: All
Ages: 5 Years – 8 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Goa Dental College

Location: Goa Dental College and Hospital Bambolim Goa

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.

Eligibility Criteria

Inclusion Criteria: * Normal, healthy children between five and eight years of age * Frankl's behavior rating: positive or definitely positive * Primary mandibular molars diagnosed with irreversible pulpitis * Intact crown structure suitable for rubber dam placement * Intraoral periapical radiograph showing primary molars with at least two-thirds of each root remaining Exclusion Criteria: * Children with special healthcare needs or systemic medical conditions * Frankl's behavior rating: negative or definitely negative * Primary molars with unrestorable crown structure * Teeth with severe mobility or pathological root resorption * Children or parents who refused to participate in the study

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07702877). StuddyBuddy aggregates publicly available trial information.