Root Canal Preparation of Infected Primary MolarsNCT04279041
In-vitro and In-vivo Comparative Evaluation of Rotary Fanta and Zunba Files in Root Canal Preparation of Infected Primary Molars
A study testing root canal preparation in people with Root Canal Preparation of Infected Primary Molars, run by Ahmad Elheeny at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Preparation of Infected Primary Molars
- What is being tested?
- root canal preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Feb 2020to 23 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Uncooperativeness of child and/or parents or caregiver's behavior.
- Unrestorable tooth.
- Presence of calcific metamorphosis inside root canals.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- root canal preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
root canal preparationProcedure or surgery
root canal preparation
| Study group | Role | What they receive |
|---|---|---|
| Fanta and Zunba rotatory files | Experimental | Fanta and Zunba rotatory files Receives: Procedure: root canal preparation |
| manual K-files | Active comparator | manual K-files Receives: Procedure: root canal preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical success rate
Presence or abscnce (+/-) of pain, mobility and/or fistulous tract
Measured: 12 month
radiographic success rate
Presence or abscnce (+/-) of periapical rdiolucency
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start19 Feb 2020
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Root Canal Preparation of Infected Primary MolarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Elheeny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmad Elheeny, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279041
- Sponsor's protocol ID
- 260
- Status last verified
- Feb 2021
- First submitted
- 18 Feb 2020
- Last updated
- 25 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40616048
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-vitro and In-vivo Comparative Evaluation of Rotary Fanta and Zunba Files in Root Canal Preparation of Infected Primary Molars
- ClinicalTrials.gov ID
- NCT04279041
- Acronym / sponsor ID
- 260
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ahmad ElheenyUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fanta and Zunba rotatory files | Experimental | Procedure: root canal preparationFanta and Zunba rotatory files |
| manual K-files | Active comparator | Procedure: root canal preparationmanual K-files |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Uncooperativeness of child and/or parents or caregiver's behavior.
- Unrestorable tooth.
- Presence of calcific metamorphosis inside root canals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| root canal preparationroot canal preparation | Procedure or surgery | Fanta and Zunba rotatory files, manual K-files |
Primary outcome
clinical success rate
Time frame: 12 month
Presence or abscnce (+/-) of pain, mobility and/or fistulous tract
radiographic success rate
Time frame: 12 month
Presence or abscnce (+/-) of periapical rdiolucency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 40616048Abd 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing root canal preparation in people with Root Canal Preparation of Infected Primary Molars, run by Ahmad Elheeny at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical success rate (time frame: 12 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.