Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars

February 16, 2026 updated by: Amira Mohamed Ibrahim Mohamed Ibrahim, Cairo University

Evaluation of Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars - A Randomized Clinical Trial (RCT)

The primary aim is to compare the behavior of the children during using conventional manual instrumentation versus rotary instrumentation by single rotary system for pulpectomy in primary molars through a Randomized Clinical Trial.

The main question it aims to answer is:

Is there a difference in the behavior of the children when using single rotary file system versus manual instrumentation in pulpectomy in primary molars?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pulpectomy has gained popularity in the pediatric dental practice for preserving the primary teeth in its position until exfoliation. There has been a paradigm shift from using manual instrumentation to rotary instrumentation for canal preparation in primary teeth. While studies show that there is a reduction in the instrumentation time with the use of rotary instruments which in turn influences the behavior of the child, its direct effect on the behavior of the children has not been evaluated .

The behavior of children plays an integral component and is the primary requisite of the pediatric dental practice. Assessment of child's behavior during a dental procedure is one of the most important skills of a pediatric dentist for successful completion of the dental treatment .

Interestingly, it has been noted that the treatment duration of patients with anxiety or behavior management problem is on average 40% more than that of normal patients going through the same procedure .

Much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure. These challenges lead to the introduction of rotary endodontics in pediatric dentistry. However, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. Various modified protocols have been introduced to overcome such barriers to prevent undesirable complications.

With these options, dentists can perform the pulpectomy with less psychological trauma to the child thus decreasing the anxiety and instilling positive behavior. The acceptance rate of the proposed method of treatment by the child may also increase. Furthermore, the use of a rotary file system may maintain a balance between the treatment duration and efficient behavior management in children.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients:

    • Aged 4-6years, Medically free and Cooperative.

  • Teeth:

    • Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.

Pre-operative Radiographic criteria:

  • Absence of internal or external root resorption.
  • Absence of periapical or inter-radicular radiolucencies.

Exclusion Criteria:

  • Patients:

    • Uncooperative children.
    • Children with systemic disease.
    • Physical or mental disabilities.
    • Refusal of participation.
    • Unable to attend follow- up visits.
    • Refusal to sign the informed consent.

Teeth:

  • Previously accessed teeth.
  • Mobile mandibular primary molars.
  • Pain on percussion.
  • Swelling in the vestibule or on palpation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I pulpectomy using single rotary file system
Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, the root canal patency was checked for all the canals located using a size #10 (0.02%) k-file then a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline.
Device: Fanta AF F one rotary files 20 taper 4
single rotary file system Fanta AF F one rotary files 20 taper 4
Active Comparator: Group II pulpectomy using manual files system
Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, manual files (k files, Mani, Inc., Japan) size 15,20,25,30 will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion, irrigation with saline.
Device: Manual files (k files ,Mani, Inc., Japan).
manual files (k files, Mani, Inc., Japan) size 15,20,25,30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• child's behavior level
Time Frame: Immediately after treatment

child's behavior level using Frankl's 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obturation quality
Time Frame: Immediately after treatment.
Periapical radiograph (Using Coll and Sadrian criteria)
Immediately after treatment.
Instrumentation time
Time Frame: During treatment
using stopwatch
During treatment
Post-operative 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.

0 - None: No pain present.

  1. - Mild: Pain is present but not distracting; easily ignored.
  2. - Moderate: Pain is distracting; manageable but limits activities.
  3. - Severe: Intense pain; unable to concentrate, requires immediate action or medication.
at 6, 12, 24, 48 and 72 hours and 1 week after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 10, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pedo departmenCairo University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data is available with the corresponding author on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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