In-vitro and In-vivo Comparative Evaluation of Rotary Fanta and Zunba Files in Root Canal Preparation of Infected Primary Molars

February 24, 2021 updated by: Ahmad Elheeny

Adequate shaping and cleaning, followed by a good coronal seal, are prerequisites for a favorable outcome. The goal of root canal preparation is to create optimized canal geometry to allow effective irrigation and obturation with preservation of the original canal morphology.

The aim of current study is to evaluate the effectiveness of Fanta and Zunba rotatory instruments in cleaning of infected root canal of primary molars to those instrumented with manual K-files.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

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 Locations

  • Egypt
      • Minya, Egypt, 61111
        • Minia University

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

4 years to 7 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Class I or II according to American Society of Anesthesiologists (ASA)
  • Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain
  • Pathological tooth mobility
  • Percussion sensitivity
  • Swelling close to involved tooth accompanied with or without fistula
  • The extension of radiolucency at the furcation area did not exceed half of the space between the furcation and the permanent successor
  • No internal root resorption
  • External root resorption (Physiologic or pathologic) limited to apical third and with at least two-third root intact

Exclusion Criteria:

  • Uncooperativeness of child and/or parents or caregiver's behavior.
  • Unrestorable tooth.
  • Presence of calcific metamorphosis inside root canals.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fanta and Zunba rotatory files
Procedure: root canal preparation
root canal preparation
ACTIVE_COMPARATOR: manual K-files
Procedure: root canal preparation
root canal preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical success rate
Time Frame: 12 month
Presence or abscnce (+/-) of pain, mobility and/or fistulous tract
12 month
radiographic success rate
Time Frame: 12 month
Presence or abscnce (+/-) of periapical rdiolucency
12 month

Collaborators and Investigators

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

Sponsor

Ahmad Elheeny

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 (ACTUAL)

February 19, 2020

Primary Completion (ACTUAL)

February 23, 2021

Study Completion (ACTUAL)

February 23, 2021

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (ACTUAL)

February 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 260

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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