Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy

NCT07672990 | Not Yet Recruiting

• 1 other identifier: CU-rania-2026
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pulpectomy

Keywords

EndoArt Pedo Blue; fanta Baby; instrumentation time; obturation quality; pulpectomy using rotary files; rotary files in primary molars

Outcome Measures

Primary Outcomes (1)

• 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

  same visit while performing the pulpectomy

Secondary Outcomes (1)

• obturation quality

  same visit after pulpectomy completion

Study Arms (2)

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

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.

Device: Pediatric NiTi rotary files manufactured with blue wire technology

Interventions

Pediatric NiTi rotary files manufactured with AF-H Wire technology DEVICE

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 AF-H Wire technology

Pediatric NiTi rotary files manufactured with blue wire technology DEVICE

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.

Pediatric NiTi rotary files manufactured with blue wire technology

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Sara A. Mahmoud, Professor

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Rania F. Mohamed, bachelor

CONTACT

+01000416751; rania.fathy@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: June 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share