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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Procedure: Rotary Instrumentation; Procedure: 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.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aya G Abd elzaher, master; Phone Number: +01100480444; Email: aya_gamal@dentistry.cu.edu.eg
• Study Contact Backup: Name: Hanaa A Abd el moniem; Email: hanaa.ibraheem@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Egypt
    • Cairo, Egypt, Egypt, 11411
      • Faculty of Dentistry, Cairo University
      • Contact: Aya G Abd elzaher, master; Phone Number: +01100480444; Email: aya_gamal@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rotary Instrumentation Group; Single Rotary File System	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.
Experimental: Manual Instrumentation Group; Manual Stainless Steel K-File Instrumentation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracanal Bacterial Load Reduction	Reduction in intracanal bacterial count after chemo-mechanical preparation during pulpectomy of primary molars. Microbiological samples will be collected from the root canals before instrumentation (S1) and after completion of instrumentation (S2) using sterile paper points. Samples will be cultured on brain heart infusion agar plates, and bacterial growth will be quantified by counting colony-forming units (CFU). The difference in CFU between S1 and S2 will be used to determine the level of bacterial reduction achieved by rotary instrumentation compared with manual instrumentation.	Immediately before instrumentation and immediately after completion of chemo-mechanical preparation during the same treatment visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Asking the patient and/or Guardian using a 4-point pain scale, the parent of each participant will receive 6 flashcards that include four faces and a word describing each face.	at 6, 12, 24, 48, and 72 hours and 1 week after treatment.
child's behavior level.	will be recorded by using the FRANKEL behavior rating scale: rate 1 means definitely negative "refusal of treatment, fearfulness"; rate 2 means negative "reluctance to accept treatment, uncooperative"; rate 3 means positive "acceptance of treatment, patient follows the dentist's directions"; Rate 4 means definitely positive "good rapport with the dentist, laughter, and enjoyment."	Immediately after treatment.
Instrumentation time	stopwatch	during the procedure, starting from anesthesia till end of procedure
Clinical success	absence of swelling will be recorded by visual examination; absence of sinus or fistula will be recorded by visual examination; pathologic mobility will be recorded by mobility test (pressure using the end of two dental mirrors)	At 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Gihan M Abu elniel, professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pulpectomy; primary molars; Pediatric endodontics; Intracanal bacterial reduction; Endodontic treatment in children; Chemo-mechanical preparation; Bacterial load reduction
• Other Study ID Numbers: pedo-3-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No