NCT03964766

Brief Summary

One of the major concerns in pediatric dentistry is premature loss of necrotic primary teeth which may cause a deleterious effect on the growth of the facial skeletal complex. In order to sustain the primary tooth as a natural space maintainer, pulpectomy is considered the treatment of choice. The essential part of endodontic treatment is to shape and clean the root canal effectively from infected tissue with microbial reduction, whilst maintaining the original configuration without creating any procedural errors . Even though, manual instrumentation as used for that purpose in deciduous teeth, presents some limitation concerning root canal cleaning, anatomical fidelity and chair-side time. To achieve successful pulpectomy technique for the primary dentition in a fast and simple procedure, with short chair time as well as effective debridement of the root canals, rotary instrumentation is one of the methods recommended over the manual.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Status
unknown

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

May 16, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

July 19, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

May 16, 2019

Last Update Submit

July 17, 2019

Conditions

ChronicInfection

Keywords

rotary filesPrimary molarPulpectomy

Outcome Measures

Primary Outcomes (4)

  • Postoperative pain: modified wong-baker pain rating scale

    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.

    12 hours

  • postoperative pain: modified wong-baker pain rating scale

    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.

    24 hours

  • postoperative pain: modified wong-baker pain rating scale

    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.

    48 hours

  • Postoperative pain: modified wong-baker pain rating scale

    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.

    72 hours

Secondary Outcomes (5)

  • Tenderness to percussion

    Up to 1 year

  • Fistula

    Up to 1 year

  • Instrumentation time

    15 Minutes

  • Furcation or periapical radiolucency

    6 month

  • Furcation or periapical radiolucency

    12 month

Study Arms (2)

rotary instrumentation

EXPERIMENTAL

endodontic treatment will be performed with the use of pedo rotary files that will be activated by engine

Device: Rotary instrumentation

hand istrumentation

ACTIVE COMPARATOR

endodontic treatment will be performed with the use of conventional hand files

Device: Hand instrumentation

Interventions

Rotary instrumentationDEVICE

using pedo rotary files in cleaning and shaping the root canals of infected primary molars

rotary instrumentation
Hand instrumentationDEVICE

using conventional hand files in cleaning and shaping the root canals of infected primary molars

hand istrumentation

Eligibility Criteria

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

You may qualify if:

  • Primary posterior teeth requiring pulpectomy.
  • Cooperative patient in age range from 4 to 6 years
  • Absence of internal or external pathologic root resorption.
  • Presence of adequate coronal tooth structure.
  • Two-thirds of each root remaining.
  • Parent or guardian agree for participant in the study

You may not qualify if:

  • Excessive mobility.
  • Children lacking cooperative ability.
  • Children with underlying systemic disease.
  • Children with special health care needs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Panchal V, Jeevanandan G, Subramanian E. Comparison of instrumentation time and obturation quality between hand K-file, H-files, and rotary Kedo-S in root canal treatment of primary teeth: A randomized controlled trial. J Indian Soc Pedod Prev Dent. 2019 Jan-Mar;37(1):75-79. doi: 10.4103/JISPPD.JISPPD_72_18.

    PMID: 30804311BACKGROUND

  • Makarem A, Ravandeh N, Ebrahimi M. Radiographic assessment and chair time of rotary instruments in the pulpectomy of primary second molar teeth: a randomized controlled clinical trial. J Dent Res Dent Clin Dent Prospects. 2014 Spring;8(2):84-9. doi: 10.5681/joddd.2014.015. Epub 2014 Jun 11.

    PMID: 25093051BACKGROUND

  • Panchal V, Jeevanandan G, Subramanian EMG. Comparison of post-operative pain after root canal instrumentation with hand K-files, H-files and rotary Kedo-S files in primary teeth: a randomised clinical trial. Eur Arch Paediatr Dent. 2019 Oct;20(5):467-472. doi: 10.1007/s40368-019-00429-5. Epub 2019 Mar 12.

    PMID: 30864090BACKGROUND

Related Links

MeSH Terms

Conditions

Bronchiolitis Obliterans SyndromeInfections

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Fatma Abdelgawad, PhD

    Lecturer of Pediatric Dentistry

    STUDY DIRECTOR

  • Kamal El Motayam, PhD

    Professor of Pediatric Dentistry

    STUDY CHAIR

Central Study Contacts

azhar al-wesabi

CONTACT

01023725522azharali5255@gmail.com

Fatma Abdelgawad, PhD

CONTACT

fatma.abdelgawad@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phD student

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 28, 2019

Study Start

December 1, 2019

Primary Completion

December 1, 2021

Study Completion

February 1, 2022

Last Updated

July 19, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will share

after thesis defense. the study will be published internationally to be available for everyone

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
study will be available within 2 year.
Access Criteria
Not yet