PulpectomyNCT07672990
Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy
A study testing Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue wire technology in people with Pulpectomy, run by Cairo University.
Trial summary
Preserving primary teeth is essential for maintaining normal chewing, speech development, and psychological well-being. Successful pulpectomy depends on effective chemomechanical preparation of the root canals while preserving their original anatomy. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpectomy
- What is being tested?
- Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue wire technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Cooperative children.
- Children between the ages of four and eight years.
- Restorable teeth with irreversible pulpitis.
- Continuous bleeding after amputation of coronal pulp tissue.
Who cannot join
- Molars that exhibit physiologic root resorption in excess of one-third.
- Internal and external root resorption.
- Presence of dental abscess, sinus tract or excessive mobility.
- Acute spreading infection/cellulitis not manageable with local treatment.
- Large periapical/furcation lesion with poor prognosis.
- Teeth close to natural exfoliation.
- Children with known allergies to study materials or medications used.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy :(A Randomized Clinical Trial)
Preserving primary teeth is essential for maintaining normal chewing, speech development, and psychological well-being. Successful pulpectomy depends on effective chemomechanical preparation of the root canals while preserving their original anatomy. Although hand files are traditionally used for canal preparation in primary teeth, they are time-consuming and may increase the risk of procedural errors. Nickel-titanium (Ni-Ti) rotary systems have gained popularity because they improve canal shaping and reduce instrumentation time. Among these systems, Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue Wire technology are specifically designed for pediatric use. However, evidence regarding their clinical performance remains limited, highlighting the need to compare their effectiveness, particularly in terms of instrumentation time and obturation quality
- Conditions
- Pulpectomy
- Being tested
- Pediatric NiTi rotary files manufactured with AF-H Wire technology, Pediatric NiTi rotary files manufactured with blue wire technology
- Keywords
- EndoArt Pedo Blue, fanta Baby, instrumentation time, obturation quality, pulpectomy using rotary files, rotary files in primary molars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric NiTi rotary files manufactured with AF-H Wire technologyDevice
After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using pediatric NiTi rotary files manufactured with AF-H Wire technology with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex and zinc oxide eugenol, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.
Pediatric NiTi rotary files manufactured with blue wire technologyDevice
After preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using blue technology wire rotary files with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric NiTi rotary files manufactured with AF-H Wire technology | Active comparator | Pediatric NiTi rotary files manufactured with AF-H Wire technology are designed to improve flexibility and cyclic fatigue resistance while facilitating efficient canal preparation. Clinical studies have reported significantly reduced instrumentation time using this rotary system compared with conventional hand instrumentation. Furthermore, the system has demonstrated favorable canal shaping ability and a high percentage of optimally obturated canals, indicating its effectiveness in pediatric pulpectomy procedures Receives: Device: Pediatric NiTi rotary files manufactured with AF-H Wire technology |
| Pediatric NiTi rotary files manufactured with blue wire technology | Experimental | Pediatric NiTi rotary files manufactured with blue wire technology are a newer pediatric rotary system developed using blue heat-treated NiTi technology. Heat treatment enhances flexibility, resistance to cyclic fatigue, and fracture resistance, which are important characteristics when preparing the curved canals of primary teeth. Laboratory studies have shown that blue wire pediatric rotary files exhibit excellent mechanical properties and superior cyclic fatigue resistance compared with several other pediatric rotary systems. However, clinical evidence evaluating its performance in terms of instrumentation efficiency and obturation quality remains limited. Receives: Device: Pediatric NiTi rotary files manufactured with blue wire technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
instumentation time
The total instrumentation time will be recorded from the start of the procedure until the canals are fully prepared. Timing will begin with the insertion of the first file and will end after the final irrigation. It will be measured in minutes using a stopwatch
Measured: same visit while performing the pulpectomy
Secondary outcomes (1)
obturation quality
The quality of obturation will be evaluated according to the criteria of Coll and Sadrian criteria (1996). The apical seal will measured in millimeters from the apical end of the canal filling material to the radiographic apex and scored as 1, 2, or 3.
- Apical seal
- Score 1 (Underfilling): was defined as filling in all canals extending more than 2 mm short of the apex.
- Score 2 (Ideal filling) was considered when the material reached up to 2 mm short of the radiographic apex or reached the working length in one or more canals.
- Score 3 (Overfilling) was recorded when the obturating material extended beyond the radiographic apex.
- Voids Obturated canals will be assessed for the presence or absence of voids.
Measured: same visit after pulpectomy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpectomyStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Fathy Mohammed Mohammed, Cairo University
- Investigators
- Sara A. Mahmoud, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672990
- Sponsor's protocol ID
- CU-rania-2026
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2026
- Last updated
- 1 Jul 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy :(A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07672990
- Acronym / sponsor ID
- CU-rania-2026
- Conditions
- Pulpectomy
- Keywords
- EndoArt Pedo Blue, fanta Baby, instrumentation time, obturation quality, pulpectomy using rotary files, rotary files in primary molars
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 29 Jun 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.
Preserving primary teeth is essential for maintaining normal chewing, speech development, and psychological well-being. Successful pulpectomy depends on effective chemomechanical preparation of the root canals while preserving their original anatomy. Although hand files are traditionally used for canal preparation in primary teeth, they are time-consuming and may increase the risk of procedural errors. Nickel-titanium (Ni-Ti) rotary systems have gained popularity because they improve canal shaping and reduce instrumentation time. Among these systems, Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue Wire technology are specifically designed for pediatric use. However, evidence regarding their clinical performance remains limited, highlighting the need to compare their effectiveness, particularly in terms of instrumentation time and obturation quality
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric NiTi rotary files manufactured with AF-H Wire technology | Active comparator | Device: Pediatric NiTi rotary files manufactured with AF-H Wire technologyPediatric NiTi rotary files manufactured with AF-H Wire technology are designed to improve flexibility and cyclic fatigue resistance while facilitating efficient canal preparation. Clinical studies have reported significantly reduced instrumentation time using this rotary system compared with conventional hand instrumentation. Furthermore, the system has demonstrated favorable canal shaping ability and a high percentage of optimally obturated canals, indicating its effectiveness in pediatric pulpectomy procedures |
| Pediatric NiTi rotary files manufactured with blue wire technology | Experimental | Device: Pediatric NiTi rotary files manufactured with blue wire technologyPediatric NiTi rotary files manufactured with blue wire technology are a newer pediatric rotary system developed using blue heat-treated NiTi technology. Heat treatment enhances flexibility, resistance to cyclic fatigue, and fracture resistance, which are important characteristics when preparing the curved canals of primary teeth. Laboratory studies have shown that blue wire pediatric rotary files exhibit excellent mechanical properties and superior cyclic fatigue resistance compared with several other pediatric rotary systems. However, clinical evidence evaluating its performance in terms of instrumentation efficiency and obturation quality remains limited. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy Cooperative children.
- Children between the ages of four and eight years.
- Restorable teeth with irreversible pulpitis.
- Continuous bleeding after amputation of coronal pulp tissue.
Key exclusion criteria (7 listed)
- Molars that exhibit physiologic root resorption in excess of one-third.
- Internal and external root resorption.
- Presence of dental abscess, sinus tract or excessive mobility.
- Acute spreading infection/cellulitis not manageable with local treatment.
- Large periapical/furcation lesion with poor prognosis.
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 |
|---|---|---|
| Pediatric NiTi rotary files manufactured with AF-H Wire technologyAfter preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using pediatric NiTi rotary files manufactured with AF-H Wire technology with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex and zinc oxide eugenol, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria. | Device | Pediatric NiTi rotary files manufactured with AF-H Wire technology |
| Pediatric NiTi rotary files manufactured with blue wire technologyAfter preoperative radiographic assessment and administration of local anesthesia, lower primary molars will be isolated using a rubber dam and caries will be removed. Working length will be determined radiographically, and root canal preparation will be performed using blue technology wire rotary files with 1% sodium hypochlorite irrigation between files. Instrumentation time will be recorded throughout the procedure. The canals will then be dried and obturated with Metapex, followed by restoration with glass ionomer cement and a stainless steel crown. Obturation quality will be evaluated postoperatively using digital radiography according to the Coll and Sadrian criteria. | Device | Pediatric NiTi rotary files manufactured with blue wire technology |
Primary outcome
instumentation time
Time frame: same visit while performing the pulpectomy
The total instrumentation time will be recorded from the start of the procedure until the canals are fully prepared. Timing will begin with the insertion of the first file and will end after the final irrigation. It will be measured in minutes using a stopwatch
1 secondary outcome
obturation quality
Time frame: same visit after pulpectomy completion
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 1 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Pulpectomy
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Pulpectomy, Pulpitis - Irreversible
Recruiting
Child's Behavior Using Single Rotary File System Versus Manual Instrumentation in Pulpectomy of Primary Molars
Irreversible Pulpitis
Active, not recruitingObservational study
Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Pulpitis - Irreversible, Pulp Necroses
RecruitingPhase 2
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
Deep Caries
Not yet recruiting
This Clinical Trial Aims to Compare the Effectiveness of Two Intra-pulpal Cryotherapy Techniques-Endo-ice and Ice Sticks-in Decreasing Intra-operative Pain and Enhancing the Success of Local Anesthesia During Pulpectomy of Mandibular Molars With Symptomatic Irreversible Pulpitis.
Root Canal Treatment, Intra-operative Pain
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.
Sara A. Mahmoud, Professor study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric NiTi rotary files manufactured with AF-H Wire technology and Pediatric NiTi rotary files manufactured with blue wire technology in people with Pulpectomy, run by Cairo University.
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 4 inclusion and 7 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Rania F. Mohamed, bachelor (+01000416751, rania.fathy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
instumentation time (time frame: same visit while performing the pulpectomy). 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 1 Jul 2026.