Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy :(A Randomized Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 30
- Primary Endpoint
- instumentation time
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- obturation quality(same visit after pulpectomy completion)
Investigators
Rania Fathy Mohammed Mohammed
principal investigator
Cairo University