Irreversible PulpitisNCT07415694
Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars
A study testing Fanta AF F one rotary files 20 taper 4 and Manual files (k files ,Mani, Inc., Japan). in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
The primary aim is to compare the behavior of the children during using conventional manual instrumentation versus rotary instrumentation by single rotary system for pulpectomy in primary molars through a Randomized Clinical Trial. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Fanta AF F one rotary files 20 taper 4 and Manual files (k files ,Mani, Inc., Japan).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2026to 25 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients:
- Aged 4-6years, Medically free and Cooperative.
- Teeth:
- Restorable mandibular second primary molars with clinical signs or symptoms of irreversible pulpitis.
- Pre-operative Radiographic criteria:
- Absence of internal or external root resorption.
- Absence of periapical or inter-radicular radiolucencies.
Who cannot join
- Patients:
- Uncooperative children.
- Children with systemic disease.
- Physical or mental disabilities.
- Refusal of participation.
- Unable to attend follow- up visits.
Show all 12Show fewer
- Refusal to sign the informed consent.
- Teeth:
- Previously accessed teeth.
- Mobile mandibular primary molars.
- Pain on percussion.
- Swelling in the vestibule or on palpation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hanaa A Abd El Moniem, Phd contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo, 11411
amira m ibrahim, master, +201002585750, amira-mohamed@dentistry.cu.edu.eg
hanaa a Abd El Moniem, phd, hanaa.ibraheem@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars - A Randomized Clinical Trial
The primary aim is to compare the behavior of the children during using conventional manual instrumentation versus rotary instrumentation by single rotary system for pulpectomy in primary molars through a Randomized Clinical Trial.
The main question it aims to answer is:
Is there a difference in the behavior of the children when using single rotary file system versus manual instrumentation in pulpectomy in primary molars?
Read the detailed description
Pulpectomy has gained popularity in the pediatric dental practice for preserving the primary teeth in its position until exfoliation. There has been a paradigm shift from using manual instrumentation to rotary instrumentation for canal preparation in primary teeth. While studies show that there is a reduction in the instrumentation time with the use of rotary instruments which in turn influences the behavior of the child, its direct effect on the behavior of the children has not been evaluated .
The behavior of children plays an integral component and is the primary requisite of the pediatric dental practice. Assessment of child's behavior during a dental procedure is one of the most important skills of a pediatric dentist for successful completion of the dental treatment .
Interestingly, it has been noted that the treatment duration of patients with anxiety or behavior management problem is on average 40% more than that of normal patients going through the same procedure .
Much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure. These challenges lead to the introduction of rotary endodontics in pediatric dentistry. However, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. Various modified protocols have been introduced to overcome such barriers to prevent undesirable complications.
With these options, dentists can perform the pulpectomy with less psychological trauma to the child thus decreasing the anxiety and instilling positive behavior. The acceptance rate of the proposed method of treatment by the child may also increase. Furthermore, the use of a rotary file system may maintain a balance between the treatment duration and efficient behavior management in children.
- Conditions
- Irreversible Pulpitis
- Being tested
- Fanta AF F one rotary files 20 taper 4, Manual files (k files ,Mani, Inc., Japan).
- Keywords
- pulpectomy, single rotary file instrumentation, manual instrumentation, primary molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fanta AF F one rotary files 20 taper 4Device
single rotary file system Fanta AF F one rotary files 20 taper 4
Manual files (k files ,Mani, Inc., Japan).Device
manual files (k files, Mani, Inc., Japan) size 15,20,25,30
| Study group | Role | What they receive |
|---|---|---|
| Group I pulpectomy using single rotary file system | Experimental | Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, the root canal patency was checked for all the canals located using a size #10 (0.02%) k-file then a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline. Receives: Device: Fanta AF F one rotary files 20 taper 4 |
| Group II pulpectomy using manual files system | Active comparator | Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, manual files (k files, Mani, Inc., Japan) size 15,20,25,30 will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion, irrigation with saline. Receives: Device: Manual files (k files ,Mani, Inc., Japan). |
What is being measured
The primary outcome is the main question the study is designed to answer.
• child's behavior level
child's behavior level using Frankl's behavior rating scale
- rate 1 means definitely negative "refusal of treatment , fearfulness"
- rate 2 means negative "reluctance to accept treatment , uncooperative"
- rate 3 means positive "acceptance of treatment , patient follows the dentist's directions"
- rate 4 means definitely positive " good rapport with the dentist , laughter and enjoyment"
Measured: Immediately after treatment
Secondary outcomes (3)
Post-operative pain
Asking the patient and/or Guardian using a 4-point pain scale, the parent of each participant will receive 6 flashcards that include four faces and a word describing each face.
0 - None: No pain present.
- - Mild: Pain is present but not distracting; easily ignored.
- - Moderate: Pain is distracting; manageable but limits activities.
- - Severe: Intense pain; unable to concentrate, requires immediate action or medication.
Measured: at 6, 12, 24, 48 and 72 hours and 1 week after treatment.
Obturation quality
Periapical radiograph (Using Coll and Sadrian criteria)
Measured: Immediately after treatment.
Instrumentation time
using stopwatch
Measured: During treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start25 Jul 2026
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohamed Ibrahim Mohamed Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415694
- Sponsor's protocol ID
- Pedo departmenCairo University
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data is available with the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07415694
- Acronym / sponsor ID
- Pedo departmenCairo University
- Conditions
- Irreversible Pulpitis
- Keywords
- pulpectomy, single rotary file instrumentation, manual instrumentation, primary molar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Jul 2026 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Jan 2028 (estimated)
- First posted
- 17 Feb 2026 (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.
The primary aim is to compare the behavior of the children during using conventional manual instrumentation versus rotary instrumentation by single rotary system for pulpectomy in primary molars through a Randomized Clinical Trial.
The main question it aims to answer is:
Is there a difference in the behavior of the children when using single rotary file system versus manual instrumentation in pulpectomy in primary molars?
Detailed description
Pulpectomy has gained popularity in the pediatric dental practice for preserving the primary teeth in its position until exfoliation. There has been a paradigm shift from using manual instrumentation to rotary instrumentation for canal preparation in primary teeth. While studies show that there is a reduction in the instrumentation time with the use of rotary instruments which in turn influences the behavior of the child, its direct effect on the behavior of the children has not been evaluated .
The behavior of children plays an integral component and is the primary requisite of the pediatric dental practice. Assessment of child's behavior during a dental procedure is one of the most important skills of a pediatric dentist for successful completion of the dental treatment .
Interestingly, it has been noted that the treatment duration of patients with anxiety or behavior management problem is on average 40% more than that of normal patients going through the same procedure .
Much attention has been directed toward making pulpectomy a less time-consuming and a more-efficient procedure. These challenges lead to the introduction of rotary endodontics in pediatric dentistry. However, the bizarre root canal morphology and thinner root dentin limited the use of rotary endodontics in primary teeth. Various modified protocols have been introduced to overcome such barriers to prevent undesirable complications.
With these options, dentists can perform the pulpectomy with less psychological trauma to the child thus decreasing the anxiety and instilling positive behavior. The acceptance rate of the proposed method of treatment by the child may also increase. Furthermore, the use of a rotary file system may maintain a balance between the treatment duration and efficient behavior management in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I pulpectomy using single rotary file system | Experimental | Device: Fanta AF F one rotary files 20 taper 4Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, the root canal patency was checked for all the canals located using a size #10 (0.02%) k-file then a single rotary file (20 taper 4) will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion at the rotational speed 300 rpm with torque set at the lowest level, irrigation with saline. |
| Group II pulpectomy using manual files system | Active comparator | Device: Manual files (k files ,Mani, Inc., Japan).Administration of local anesthesia at the side of the affected tooth. Application of the rubber dam for isolation, then a standardized pulpectomy procedure will be performed using a large sterile round end bur in a high-speed hand piece with copious irrigation. After opening the access cavity, manual files (k files, Mani, Inc., Japan) size 15,20,25,30 will be adjusted on the desirable working length depending on an electronic apex locator (1 mm shorter than the apex) and used in pulpectomy in a brushing motion, irrigation with saline. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patients:
- Teeth:
- Absence of internal or external root resorption.
- Absence of periapical or inter-radicular radiolucencies.
Key exclusion criteria (12 listed)
- Patients:
- Previously accessed teeth.
- Mobile mandibular primary molars.
- Pain on percussion.
- Swelling in the vestibule or on palpation.
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 |
|---|---|---|
| Fanta AF F one rotary files 20 taper 4single rotary file system Fanta AF F one rotary files 20 taper 4 | Device | Group I pulpectomy using single rotary file system |
| Manual files (k files ,Mani, Inc., Japan).manual files (k files, Mani, Inc., Japan) size 15,20,25,30 | Device | Group II pulpectomy using manual files system |
Primary outcome
• child's behavior level
Time frame: Immediately after treatment
child's behavior level using Frankl's behavior rating scale * rate 1 means definitely negative "refusal of treatment , fearfulness" * rate 2 means negative "reluctance to accept treatment , uncooperative" * rate 3 means positive "acceptance of treatment , patient follows the dentist's directions" * rate 4 means definitely positive " good rapport with the dentist , laughter and enjoyment"
3 secondary outcomes
Post-operative pain
Time frame: at 6, 12, 24, 48 and 72 hours and 1 week after treatment.
Obturation quality
Time frame: Immediately after treatment.
Instrumentation time
Time frame: During treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. data is available with the corresponding author on reasonable request
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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.
Hanaa A Abd El Moniem, Phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fanta AF F one rotary files 20 taper 4 and Manual files (k files ,Mani, Inc., Japan). in people with Irreversible Pulpitis, run by Cairo University 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact amira M ibrahim, master (+201002585750, amira-mohamed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• child's behavior level (time frame: Immediately after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.