Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 5:46 PM
Study NCT ID:
NCT07472751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Bacterial Reduction After Pulpectomy in Primary Molars
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: