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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
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.
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.
Age
4 - 6 years
Sex
ALL
Healthy Volunteers
No
Faculty of dentistry, Cairo university
Cairo, Egypt, Egypt
Start Date
April 1, 2026
Primary Completion Date
October 1, 2026
Completion Date
October 1, 2027
Last Updated
March 17, 2026
34
ESTIMATED participants
Rotary Instrumentation
PROCEDURE
Manual Instrumentation
PROCEDURE
Lead Sponsor
Cairo University
NCT07410780
NCT07290049
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07130760