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

NCT ID: NCT04279041

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-19

Study Completion Date

2021-02-23

Brief Summary

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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.

Detailed Description

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Conditions

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Root Canal Preparation of Infected Primary Molars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fanta and Zunba rotatory files

Fanta and Zunba rotatory files

Group Type EXPERIMENTAL

root canal preparation

Intervention Type PROCEDURE

root canal preparation

manual K-files

manual K-files

Group Type ACTIVE_COMPARATOR

root canal preparation

Intervention Type PROCEDURE

root canal preparation

Interventions

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root canal preparation

root canal preparation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ahmad Elheeny

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Elheeny

clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Minia University

Minya, , Egypt

Site Status

Countries

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Egypt

References

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Abd El Fatah YAM, Elheeny AAH, Ashraf Abd-Elsabour MA, Ali Khattab NM. Clinical and radiographic outcomes of pulpectomy in primary teeth using two rotary file systems compared with manual files: a cost-effectiveness analysis. BMC Oral Health. 2025 Jul 4;25(1):1093. doi: 10.1186/s12903-025-06508-y.

Reference Type DERIVED
PMID: 40616048 (View on PubMed)

Other Identifiers

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260

Identifier Type: -

Identifier Source: org_study_id

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