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NCT Number: NCT07672990

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

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

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Key information

Conditions

Pulpectomy

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. 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

  1. obturation quality

    Time frame: same visit after pulpectomy completion

    The quality of obturation will be evaluated according to the criteria of Coll and Sadrian criteria (1996). The apical seal will measured in millimeters from the apical end of the canal filling material to the radiographic apex and scored as 1, 2, or 3.

    • Apical seal
    • Score 1 (Underfilling): was defined as filling in all canals extending more than 2 mm short of the apex.
    • Score 2 (Ideal filling) was considered when the material reached up to 2 mm short of the radiographic apex or reached the working length in one or more canals.
    • Score 3 (Overfilling) was recorded when the obturating material extended beyond the radiographic apex.
    • Voids Obturated canals will be assessed for the presence or absence of voids.

Study contacts

Contact information is provided by the study sponsor or research team.

Rania F. Mohamed, bachelor

CONTACT

[email protected]

+01000416751

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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