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

NCT07672990 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-07-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Sara A. Mahmoud, Professor · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-06-30
Completion
2027-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07672990 on ClinicalTrials.gov