Evaluation of Bacterial Reduction After Pulpectomy in Primary Molars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rotary Instrumentation, Manual Instrumentation.
- Who it may be relevant to
- Registry conditions: Irreversible Pulpitis. Basic parameters: 4 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Intracanal Bacterial Load Reduction [Time frame: Immediately before instrumentation and immediately after completion of chemo-mechanical preparation during the same treatment visit.]
Secondary outcome measures (4)
- Postoperative Pain [Time frame: at 6, 12, 24, 48, and 72 hours and 1 week after treatment.]
- child's behavior level. [Time frame: Immediately after treatment.]
- Instrumentation time [Time frame: during the procedure, starting from anesthesia till end of procedure]
- Clinical success [Time frame: At 3, 6, and 12 months]
Eligibility criteria
Inclusion criteria
- Children age 4 to 6 years
- Medically free children
- Cooperative children
- Restorable mandibular second primary molars with signs or symptoms of irreversible pulpitis
- No internal root resorption on radiograph
- No external root resorption on radiograph
- No periapical radiolucency
- No inter-radicular radiolucency
Exclusion criteria
- Uncooperative children
- Children with systemic disease
- Children with physical disability
- Children with mental disability
- Refusal to participate
- Inability to attend follow-up visits
- Refusal to sign consent form
- Previously accessed teeth
- Mobile mandibular primary molars
- Pain on percussion
- Swelling on palpation or in the vestibule
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of dentistry, Cairo university — Cairo
Identifiers
NCT: NCT07472751 · pedo-3-2026