Irreversible PulpitisNCT07427420
Postoperative Pain After Pulpectomy in 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
To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, 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
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2026to 1 Oct 2027
- 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
Faculty of Dentistry, Cairo University
Cairo, Egypt, 11411
mona a amer, master, +201100877939, mona.amen@dentistry.cu.edu.eg
hanaa A Abd El Moniem, phd, hanaa.ibraheem@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Post Operative Pain Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars
To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial.
The main question it aims to answer is:
Is there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?
Read the detailed description
Endodontic procedures remain among the most commonly performed treatments following the diagnosis of pulpal inflammation or pathology. However, in primary teeth, endodontic treatment poses substantial difficulties owing to its complex anatomy and canal systems
- Maintaining a primary tooth after successful root canal treatment is highly beneficial, as the preserved tooth serves as the most effective natural spacemaintainer
- In cases of irreversible pulpitis, endodontic therapy remains the most common and frequently performed procedure to alleviate pain
- Pulpectomy in primary molars is a critical treatment modality in pediatric dentistry when the pulp is irreversibly inflamed. Traditional instrumentation for pulpectomy often relies on manual files (e.g., stainless steel K-files), which can be time-consuming, technique sensitive, and may pose challenges due to the complex and delicate root anatomy of primary teeth
- Rotary nickel-titanium (NiTi) systems have potential advantages: more efficient preparation, reduced chair-time, and possibly better patient cooperation. Indeed, study has found that rotary instrumentation significantly reduces both the instrumentation and obturation time and is associated with lower postoperative pain
- Postoperative pain is one way to measure the success of endodontic treatment
- Conditions
- Irreversible Pulpitis
- Being tested
- Fanta AF F one rotary files 20 taper 4, Manual files (k files ,Mani, Inc., Japan).
- Keywords
- single rotary file, pulpectomy, primary molars, manual instrumentation
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
Fanta AF F one rotary files 20 taper 4 single rotary file system
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.
Post-operative pain
: will be recorded by Asking the patient and/or guardian using a 4-point pain scale at 6, 12, 24, 48 and 72 hours And 1 week after treatment. 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
Secondary outcomes (4)
child's behavior level
child's behavior level: will be recorded by using FRANKEL 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)
Clinical Success
- Absence of swelling will be recorded by visual examination
- Absence of sinus or fistula: will be recorded by visual examination.
- Pathologic mobility: will be recorded by mobility test (pressure using the end of two dental mirrors)
Measured: ( At 3, 6, 12 months)
Instrumentation time
will be recorded using a stopwatch
Measured: (During procedure start from anathesia till end of procedure)
The obturation quality
will be assessed using a radiograph(Using Coll and Sadrian criteria)
Measured: (Immediately after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start10 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Adel Amer, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427420
- Sponsor's protocol ID
- MSc-pedo-pulpectomy-01
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Operative Pain Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars
- ClinicalTrials.gov ID
- NCT07427420
- Acronym / sponsor ID
- MSc-pedo-pulpectomy-01
- Conditions
- Irreversible Pulpitis
- Keywords
- single rotary file, pulpectomy, primary molars, manual instrumentation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 23 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.
To compare the post operative pain in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation, through a Randomized Clinical Trial.
The main question it aims to answer is:
Is there a difference in post operative pain when using single rotary file system versus manual instrumentation in pulpectomy of primary molars?
Detailed description
Endodontic procedures remain among the most commonly performed treatments following the diagnosis of pulpal inflammation or pathology. However, in primary teeth, endodontic treatment poses substantial difficulties owing to its complex anatomy and canal systems
- Maintaining a primary tooth after successful root canal treatment is highly beneficial, as the preserved tooth serves as the most effective natural spacemaintainer
- In cases of irreversible pulpitis, endodontic therapy remains the most common and frequently performed procedure to alleviate pain
- Pulpectomy in primary molars is a critical treatment modality in pediatric dentistry when the pulp is irreversibly inflamed. Traditional instrumentation for pulpectomy often relies on manual files (e.g., stainless steel K-files), which can be time-consuming, technique sensitive, and may pose challenges due to the complex and delicate root anatomy of primary teeth
- Rotary nickel-titanium (NiTi) systems have potential advantages: more efficient preparation, reduced chair-time, and possibly better patient cooperation. Indeed, study has found that rotary instrumentation significantly reduces both the instrumentation and obturation time and is associated with lower postoperative pain
- Postoperative pain is one way to measure the success of endodontic treatment
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:
- 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 4Fanta AF F one rotary files 20 taper 4 single rotary file system | 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
Post-operative pain
Time frame: At 6, 12, 24, 48 and 72 hours and 1 week after Treatment
: will be recorded by Asking the patient and/or guardian using a 4-point pain scale at 6, 12, 24, 48 and 72 hours And 1 week after treatment. The parent of each participant will receive 6 flashcards that include four faces and a word describing each face. 0 - None: No pain present. 1. - Mild: Pain is present but not distracting; easily ignored. 2. - Moderate: Pain is distracting; manageable but limits activities. 3. - Severe: Intense pain; unable to concentrate, requires immediate action or medication
4 secondary outcomes
child's behavior level
Time frame: (Immediately after treatment)
Clinical Success
Time frame: ( At 3, 6, 12 months)
Instrumentation time
Time frame: (During procedure start from anathesia till end of procedure)
The obturation quality
Time frame: (Immediately after 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 23 Feb 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: opening soon, as of the sponsor's last update on 23 Feb 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 Mona A amer, Master (+201100877939, mona.amen@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: At 6, 12, 24, 48 and 72 hours and 1 week 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 23 Feb 2026.