NCT07472751

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Apr 2026Oct 2027

First Submitted

Initial submission to the registry

March 6, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 6, 2026

Last Update Submit

March 13, 2026

Conditions

Irreversible Pulpitis

Keywords

Pediatric endodonticsIntracanal bacterial reductionEndodontic treatment in childrenChemo-mechanical preparationPulpectomyprimary molarsBacterial load reduction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Postoperative Pain

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

  • child's behavior level.

    Immediately after treatment.

  • Instrumentation time

    during the procedure, starting from anesthesia till end of procedure

  • Clinical success

    At 3, 6, and 12 months

Study Arms (2)

Rotary Instrumentation Group

EXPERIMENTAL

Single Rotary File System

Procedure: Rotary Instrumentation

Manual Instrumentation Group

EXPERIMENTAL

Manual Stainless Steel K-File Instrumentation

Procedure: Manual Instrumentation

Interventions

Rotary InstrumentationPROCEDURE

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.

Rotary Instrumentation Group
Manual InstrumentationPROCEDURE

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.

Manual Instrumentation Group

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry, Cairo university

Cairo, Egypt, 11411, Egypt

Location

Study Officials

  • Gihan M Abu elniel, professor

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Aya G Abd elzaher, master

CONTACT

+01100480444aya_gamal@dentistry.cu.edu.eg

Hanaa A Abd el moniem

CONTACT

hanaa.ibraheem@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The blinding of operator is not possible due to the nature of the technique used
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
candidate in department of pediatric dentistry and dental public health department, faculty of dentistry, Cairo university

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 16, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)