Irreversible PulpitisNCT07472751
Evaluation of Bacterial Reduction After Pulpectomy in Primary Molars
A study testing Rotary Instrumentation and Manual Instrumentation in people with Irreversible Pulpitis, run by Cairo University at 1 site in Egypt.
Trial summary
The primary aim of the study is to compare the bacterial reduction in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Rotary Instrumentation and Manual Instrumentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2026to 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
- No healthy volunteers
- Child
Who may be able to join
- Children age 4 to 6 years
- Medically free children
- Cooperative children
- Restorable mandibular second primary molars with signs or symptoms of irreversible pulpitis
- No internal root resorption on radiograph
- No external root resorption on radiograph
- No periapical radiolucency
- No inter-radicular radiolucency
Who cannot join
- Uncooperative children
- Children with systemic disease
- Children with physical disability
- Children with mental disability
- Refusal to participate
- Inability to attend follow-up visits
Show all 11Show fewer
- Refusal to sign consent form
- Previously accessed teeth
- Mobile mandibular primary molars
- Pain on percussion
- Swelling on palpation or in the vestibule
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 contact
Egypt1 site
Faculty of dentistry, Cairo university
Cairo, Egypt, 11411
Aya G Abd elzaher, master, +01100480444, aya_gamal@dentistry.cu.edu.eg
About this study
Official title: Comparative Evaluation of Bacterial Reduction Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars: An In Vitro and In Vivo Study
The primary aim of the study is to compare the bacterial reduction in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation.
Read the detailed description
This study aims to compare the antibacterial effectiveness of a single rotary file system with conventional manual instrumentation during pulpectomy of primary molars. The study will evaluate bacterial reduction by microbiological culture techniques using colony-forming units per milliliter (CFU/mL) before and after chemo-mechanical preparation.
This investigation will include both in vitro and in vivo components to provide a comprehensive evaluation of bacterial reduction. In the clinical part of the study, children aged 4 to 6 years with restorable mandibular second primary molars diagnosed with irreversible pulpitis will be recruited from the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department at the Faculty of Dentistry, Cairo University. Eligible teeth will undergo pulpectomy and will be randomly assigned to one of two groups:
Group 1: Pulpectomy using a single rotary file system. Group 2: Pulpectomy using conventional manual stainless-steel K-files.
Microbiological samples will be collected from the root canals before instrumentation and after completion of chemo-mechanical preparation using sterile paper points. The samples will be transferred to brain-heart infusion broth and cultured on agar plates under aerobic and anaerobic conditions. Bacterial growth will be quantified by counting colony-forming units to determine the degree of bacterial reduction produced by each instrumentation technique.
The findings of this study will contribute to evidence-based decision-making in pediatric endodontics by clarifying whether rotary instrumentation provides superior bacterial reduction compared with manual instrumentation in primary molar pulpectomy. Improved understanding of the antimicrobial effectiveness of these techniques may help clinicians select instrumentation methods that enhance treatment success, reduce chairside time, and improve patient cooperation during pediatric dental procedures.
- Conditions
- Irreversible Pulpitis
- Being tested
- Rotary Instrumentation, Manual Instrumentation
- Keywords
- Pediatric endodontics, Intracanal bacterial reduction, Endodontic treatment in children, Chemo-mechanical preparation, Pulpectomy, primary molars, Bacterial load reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotary InstrumentationProcedure or surgery
After opening the access cavity, the root canal patency will be checked for all the canals located using a size #15 (0.02%) K file, then a single rotary file (AF F One, FANTA, China) (20 taper 4) will be adjusted to the desirable working length depending on an electronic apex locator (1 mm shorter than the apex). This file will be used in the pulpectomy procedure using a brushing motion and will be irrigated with saline.
Manual InstrumentationProcedure or surgery
After opening the access cavity, manual files (K files, Mani, Inc., Japan) of sizes 15, 20, 25, and 30 will be adjusted to the desirable working length depending on an electronic apex locator (1 mm shorter than the apex). These files will be used in the pulpectomy procedure using a brushing motion and will be irrigated with saline.
| Study group | Role | What they receive |
|---|---|---|
| Rotary Instrumentation Group | Experimental | Single Rotary File System Receives: Procedure: Rotary Instrumentation |
| Manual Instrumentation Group | Experimental | Manual Stainless Steel K-File Instrumentation Receives: Procedure: Manual Instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracanal Bacterial Load Reduction
Reduction in intracanal bacterial count after chemo-mechanical preparation during pulpectomy of primary molars. Microbiological samples will be collected from the root canals before instrumentation (S1) and after completion of instrumentation (S2) using sterile paper points. Samples will be cultured on brain heart infusion agar plates, and bacterial growth will be quantified by counting colony-forming units (CFU). The difference in CFU between S1 and S2 will be used to determine the level of bacterial reduction achieved by rotary instrumentation compared with manual instrumentation.
Measured: Immediately before instrumentation and immediately after completion of chemo-mechanical preparation during the same treatment visit.
Secondary outcomes (4)
Postoperative 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.
Measured: at 6, 12, 24, 48, and 72 hours and 1 week after treatment.
child's behavior level.
will be recorded by using the 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.
Instrumentation time
stopwatch
Measured: during the procedure, starting from anesthesia till end of procedure
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, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Abd Elzaher, Cairo University
- Investigators
- Gihan M Abu elniel, professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472751
- Sponsor's protocol ID
- pedo-3-2026
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Bacterial Reduction Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars: An In Vitro and In Vivo Study
- ClinicalTrials.gov ID
- NCT07472751
- Acronym / sponsor ID
- pedo-3-2026
- Conditions
- Irreversible Pulpitis
- Keywords
- Pediatric endodontics, Intracanal bacterial reduction, Endodontic treatment in children, Chemo-mechanical preparation, Pulpectomy, primary molars, Bacterial load reduction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 16 Mar 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 of the study is to compare the bacterial reduction in pulpectomy of primary molars using a single rotary file system versus conventional manual instrumentation.
Detailed description
This study aims to compare the antibacterial effectiveness of a single rotary file system with conventional manual instrumentation during pulpectomy of primary molars. The study will evaluate bacterial reduction by microbiological culture techniques using colony-forming units per milliliter (CFU/mL) before and after chemo-mechanical preparation.
This investigation will include both in vitro and in vivo components to provide a comprehensive evaluation of bacterial reduction. In the clinical part of the study, children aged 4 to 6 years with restorable mandibular second primary molars diagnosed with irreversible pulpitis will be recruited from the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department at the Faculty of Dentistry, Cairo University. Eligible teeth will undergo pulpectomy and will be randomly assigned to one of two groups:
Group 1: Pulpectomy using a single rotary file system. Group 2: Pulpectomy using conventional manual stainless-steel K-files.
Microbiological samples will be collected from the root canals before instrumentation and after completion of chemo-mechanical preparation using sterile paper points. The samples will be transferred to brain-heart infusion broth and cultured on agar plates under aerobic and anaerobic conditions. Bacterial growth will be quantified by counting colony-forming units to determine the degree of bacterial reduction produced by each instrumentation technique.
The findings of this study will contribute to evidence-based decision-making in pediatric endodontics by clarifying whether rotary instrumentation provides superior bacterial reduction compared with manual instrumentation in primary molar pulpectomy. Improved understanding of the antimicrobial effectiveness of these techniques may help clinicians select instrumentation methods that enhance treatment success, reduce chairside time, and improve patient cooperation during pediatric dental procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotary Instrumentation Group | Experimental | Procedure: Rotary InstrumentationSingle Rotary File System |
| Manual Instrumentation Group | Experimental | Procedure: Manual InstrumentationManual Stainless Steel K-File Instrumentation |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children age 4 to 6 years
- Medically free children
- Cooperative children
- Restorable mandibular second primary molars with signs or symptoms of irreversible pulpitis
- No internal root resorption on radiograph
Key exclusion criteria (11 listed)
- Uncooperative children
- Children with systemic disease
- Children with physical disability
- Children with mental disability
- Refusal to participate
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 |
|---|---|---|
| Rotary InstrumentationAfter opening the access cavity, the root canal patency will be checked for all the canals located using a size #15 (0.02%) K file, then a single rotary file (AF F One, FANTA, China) (20 taper 4) will be adjusted to the desirable working length depending on an electronic apex locator (1 mm shorter than the apex). This file will be used in the pulpectomy procedure using a brushing motion and will be irrigated with saline. | Procedure or surgery | Rotary Instrumentation Group |
| Manual InstrumentationAfter opening the access cavity, manual files (K files, Mani, Inc., Japan) of sizes 15, 20, 25, and 30 will be adjusted to the desirable working length depending on an electronic apex locator (1 mm shorter than the apex). These files will be used in the pulpectomy procedure using a brushing motion and will be irrigated with saline. | Procedure or surgery | Manual Instrumentation Group |
Primary outcome
Intracanal Bacterial Load Reduction
Time frame: Immediately before instrumentation and immediately after completion of chemo-mechanical preparation during the same treatment visit.
Reduction in intracanal bacterial count after chemo-mechanical preparation during pulpectomy of primary molars. Microbiological samples will be collected from the root canals before instrumentation (S1) and after completion of instrumentation (S2) using sterile paper points. Samples will be cultured on brain heart infusion agar plates, and bacterial growth will be quantified by counting colony-forming units (CFU). The difference in CFU between S1 and S2 will be used to determine the level of bacterial reduction achieved by rotary instrumentation compared with manual instrumentation.
4 secondary outcomes
Postoperative Pain
Time frame: at 6, 12, 24, 48, and 72 hours and 1 week after treatment.
child's behavior level.
Time frame: Immediately after treatment.
Instrumentation time
Time frame: during the procedure, starting from anesthesia till end of procedure
Clinical success
Time frame: At 3, 6, and 12 months
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 17 Mar 2026.
- Individual participant dataSharing planned: No
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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 contact
Gihan M Abu elniel, professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotary Instrumentation and Manual Instrumentation 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 8 inclusion and 11 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 17 Mar 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 Aya G Abd elzaher, master (+01100480444, aya_gamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracanal Bacterial Load Reduction (time frame: Immediately before instrumentation and immediately after completion of chemo-mechanical preparation during the same treatment visit.). 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 17 Mar 2026.