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

NCT07415694 | Not Yet Recruiting

• 1 other identifier: Pedo departmenCairo University
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Irreversible Pulpitis

Keywords

pulpectomy; single rotary file instrumentation; manual instrumentation; primary molar

Outcome Measures

Primary Outcomes (1)

• • child's behavior level

  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 Outcomes (3)

• Post-operative pain

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

• Obturation quality

  Immediately after treatment.

• Instrumentation time

  During treatment

Study Arms (2)

Group I pulpectomy using single rotary file system

EXPERIMENTAL

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

Group II pulpectomy using manual files system

ACTIVE COMPARATOR

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).

Interventions

Fanta AF F one rotary files 20 taper 4 DEVICE

single rotary file system Fanta AF F one rotary files 20 taper 4

Group I pulpectomy using single rotary file system

Manual files (k files ,Mani, Inc., Japan). DEVICE

manual files (k files, Mani, Inc., Japan) size 15,20,25,30

Group II pulpectomy using manual files system

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, 11411, Egypt

Location

Central Study Contacts

amira M ibrahim, master

CONTACT

+201002585750; amira-mohamed@dentistry.cu.edu.eg

Hanaa A Abd El Moniem, Phd

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 the 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: principal investigator

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: April 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)