In-vitro and In-vivo Comparative Evaluation of Rotary Fanta and Zunba Files in Root Canal Preparation of Infected Primary Molars
1 other identifier
interventional
98
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2020
CompletedStudy Start
First participant enrolled
February 19, 2020
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2021
CompletedFebruary 25, 2021
February 1, 2021
1 year
February 18, 2020
February 24, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
clinical success rate
Presence or abscnce (+/-) of pain, mobility and/or fistulous tract
12 month
radiographic success rate
Presence or abscnce (+/-) of periapical rdiolucency
12 month
Study Arms (2)
Fanta and Zunba rotatory files
EXPERIMENTALFanta and Zunba rotatory files
manual K-files
ACTIVE COMPARATORmanual K-files
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Uncooperativeness of child and/or parents or caregiver's behavior.
- Unrestorable tooth.
- Presence of calcific metamorphosis inside root canals.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ahmad Elheenylead
Study Sites (1)
Minia University
Minya, 61111, Egypt
Related Publications (1)
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.
PMID: 40616048DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- clinical professor
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 20, 2020
Study Start
February 19, 2020
Primary Completion
February 23, 2021
Study Completion
February 23, 2021
Last Updated
February 25, 2021
Record last verified: 2021-02