NCT06146686

Brief Summary

The aim of this study is to compare the clinical effectiveness of a single rotary file system versus a multiple rotary files system in pulpectomy of primary molars

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

11 months

First QC Date

November 17, 2023

Last Update Submit

April 4, 2024

Conditions

Pulpitis - Irreversible

Keywords

single rotary file pulpectomy , primary molars

Outcome Measures

Primary Outcomes (1)

  • instrumentation time

    instrumentation time of pulpectomy using single rotary file by stopwatch

    during the operation

Secondary Outcomes (2)

  • child's cooperation level

    baseline and during the operation

  • obturation quality

    immediately after the operation

Study Arms (2)

Group I ( pulpectomy using single rotary file )

EXPERIMENTAL

After opening the access cavity, a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on a radiograph (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 blue rotary files 20 taper 4

Group II ( pulpectomy using multiple rotary files system )

ACTIVE COMPARATOR

After opening the access cavity, multiple rotary files system (Fanta AF baby rotary files 20 taper 4, 25 taper 4, 30 taper 4) will be adjusted on the desirable working length depending on a radiograph (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at rotational speed 300 rpm with torque set at the lowest level, irrigation with saline

Device: Fanta AF baby rotary files 20 , 25 , 30 taper 4

Interventions

Fanta AF blue rotary files 20 taper 4DEVICE

single rotary file Fanta AF blue rotary files 20 taper 4

Group I ( pulpectomy using single rotary file )
Fanta AF baby rotary files 20 , 25 , 30 taper 4DEVICE

multiple rotary files system Fanta AF baby rotary files 20 , 25 , 30 taper 4

Group II ( pulpectomy using multiple rotary files system )

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children Criteria:
  • Medically free .
  • Cooperative patient.
  • Molar criteria :
  • Mandibular second primary molar with clinical signs or symptoms of irreversible pulpitis
  • Radiographic criteria:
  • No evidence of internal/external pathologic root resorption.
  • With or without periapical or furcal lesion .

You may not qualify if:

  • Uncooperative children.
  • Children with systemic disease.
  • Lack of informed consent by the child patient's parent.
  • Refusal of participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

RECRUITING

Related Publications (2)

  • Kohli A, Chhabra J, Sharma K, Katyayan R, Bhatnagar P, Sharma A. Comparative Evaluation of Instrumentation Time and Quality of Obturation amongst Pediatric Rotary Endodontic System: An In Vivo Study. Int J Clin Pediatr Dent. 2023 Mar-Apr;16(2):338-343. doi: 10.5005/jp-journals-10005-2573.

    PMID: 37519962BACKGROUND

  • Kalita S, Agarwal N, Jabin Z, Anand A. Comparative Evaluation of Cleaning Capacity and Efficiency of Kedo-S Pediatric Rotary Files, Rotary ProTaper, and Hand K Files in Primary Molar Pulpectomy. Int J Clin Pediatr Dent. 2021 May-Jun;14(3):383-387. doi: 10.5005/jp-journals-10005-1958.

    PMID: 34720511BACKGROUND

Central Study Contacts

Mennat-Allah Eid Ahmed, MAster

CONTACT

0201119309905mennaallah-eid@dentistry.cu.edu.eg

Reem mohamed fouad, PHD

CONTACT

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. Trial participants, outcome assessors and statistician will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor , internal resident

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 27, 2023

Study Start

February 1, 2024

Primary Completion

January 1, 2025

Study Completion

April 1, 2025

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations

EG(1)