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NCT Number: NCT07472751

Evaluation of Bacterial Reduction After Pulpectomy in Primary Molars

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.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rotary Instrumentation

Procedure

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.

Manual Instrumentation

Procedure

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 outcomes

  1. Intracanal Bacterial Load Reduction

    Time frame: Immediately before instrumentation and immediately after completion of chemo-mechanical preparation during the same treatment visit.

    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.

Secondary outcomes

  1. Postoperative Pain

    Time frame: at 6, 12, 24, 48, and 72 hours and 1 week after treatment.

    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.

  2. child's behavior level.

    Time frame: Immediately after treatment.

    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."

  3. Instrumentation time

    Time frame: during the procedure, starting from anesthesia till end of procedure

    stopwatch

  4. Clinical success

    Time frame: At 3, 6, and 12 months

    • 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Aya G Abd elzaher, master

CONTACT

[email protected]

+01100480444

Hanaa A Abd el moniem

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 16, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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