NCT07472751

Evaluation of Bacterial Reduction After Pulpectomy in Primary Molars

Comparative Evaluation of Bacterial Reduction Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars: An In Vitro and In Vivo Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of the study is to compare the bacterial reduction in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation.

Detailed description

This study aims to compare the antibacterial effectiveness of a single rotary file system with conventional manual instrumentation during pulpectomy of primary molars. The study will evaluate bacterial reduction by microbiological culture techniques using colony-forming units per milliliter (CFU/mL) before and after chemo-mechanical preparation. This investigation will include both in vitro and in vivo components to provide a comprehensive evaluation of bacterial reduction. In the clinical part of the study, children aged 4 to 6 years with restorable mandibular second primary molars diagnosed with irreversible pulpitis will be recruited from the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department at the Faculty of Dentistry, Cairo University. Eligible teeth will undergo pulpectomy and will be randomly assigned to one of two groups: Group 1: Pulpectomy using a single rotary file system. Group 2: Pulpectomy using conventional manual stainless-steel K-files. Microbiological samples will be collected from the root canals before instrumentation and after completion of chemo-mechanical preparation using sterile paper points. The samples will be transferred to brain-heart infusion broth and cultured on agar plates under aerobic and anaerobic conditions. Bacterial growth will be quantified by counting colony-forming units to determine the degree of bacterial reduction produced by each instrumentation technique. The findings of this study will contribute to evidence-based decision-making in pediatric endodontics by clarifying whether rotary instrumentation provides superior bacterial reduction compared with manual instrumentation in primary molar pulpectomy. Improved understanding of the antimicrobial effectiveness of these techniques may help clinicians select instrumentation methods that enhance treatment success, reduce chairside time, and improve patient cooperation during pediatric dental procedures.

Conditions

• Irreversible Pulpitis

Interventions

Type	Name	Description
PROCEDURE	Rotary Instrumentation	After opening the access cavity, the root canal patency will be checked for all the canals located using a size #15 (0.02%) K file, then a single rotary file (AF F One, FANTA, China) (20 taper 4) will be adjusted to the desirable working length depending on an electronic apex locator (1 mm shorter than the apex). This file will be used in the pulpectomy procedure using a brushing motion and will be irrigated with saline.
PROCEDURE	Manual Instrumentation	After opening the access cavity, manual files (K files, Mani, Inc., Japan) of sizes 15, 20, 25, and 30 will be adjusted to the desirable working length depending on an electronic apex locator (1 mm shorter than the apex). These files will be used in the pulpectomy procedure using a brushing motion and will be irrigated with saline.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2026-03-16
• Last updated: 2026-03-17

Locations

1 site across 1 country: Egypt