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NOT YET RECRUITING
NCT07672990
NA

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

Sponsor: Cairo University

View on ClinicalTrials.gov

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

Official title: Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy :(A Randomized Clinical Trial)

Key Details

Gender

All

Age Range

4 Years - 8 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09

Completion Date

2027-09

Last Updated

2026-07-01

Healthy Volunteers

Yes

Conditions

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 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 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 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.