Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pediatric NiTi rotary files manufactured with AF-H Wire technology, Pediatric NiTi rotary files manufactured with blue wire technology.
- Who it may be relevant to
- Registry conditions: Pulpectomy. Basic parameters: 4 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy :(A Randomized Clinical Trial)
Overview
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
Interventions
- Device Pediatric NiTi rotary files manufactured with AF-H Wire technology
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 - Device Pediatric NiTi rotary files manufactured with blue wire technology
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 restora
Primary outcome measures
- instumentation time [Time frame: same visit while performing the pulpectomy]
Secondary outcome measures (1)
- obturation quality [Time frame: same visit after pulpectomy completion]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07672990 · CU-rania-2026