Skip to main content
OpenTrials
Completed

NCT Number: NCT07702877

Comparative Evaluation of Pediatric Rotary Files and Hand Files in Primary Molars

The goal of this clinical trial is to evaluate and compare the efficacy of Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files for biomechanical preparation during pulpectomy of primary mandibular molars in children aged 5-8 years.

The main questions it aims to answer are:

* Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems result in better obturation quality compared with manual K-files during pulpectomy of primary mandibular molars? * Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems reduce postoperative pain compared with manual K-files following pulpectomy?

Researchers will compare Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files to determine their effect on obturation quality and postoperative pain.

Participants will:

* Undergo clinical and radiographic evaluation of primary mandibular molars requiring pulpectomy. * Be randomly allocated to one of three instrumentation groups: Kedo-Nano Plus rotary files, Kedo-S Square rotary files, or manual K-files. * Receive pulpectomy treatment using the assigned instrumentation technique. * Undergo radiographic assessment of obturation quality following treatment. * Have postoperative pain assessed using the Wong-Baker Faces Pain Rating Scale at 6, 12, 24, and 48 hours after treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pulpectomy Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis Primary Teeth Indicated for Pulp Therapy

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goa Dental College and Hospital

Bambolim, Goa, 403202, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Normal, healthy children between five and eight years of age
  • Frankl's behavior rating: positive or definitely positive
  • Primary mandibular molars diagnosed with irreversible pulpitis
  • Intact crown structure suitable for rubber dam placement
  • Intraoral periapical radiograph showing primary molars with at least two-thirds of each root remaining

Exclusion criteria

  • Children with special healthcare needs or systemic medical conditions
  • Frankl's behavior rating: negative or definitely negative
  • Primary molars with unrestorable crown structure
  • Teeth with severe mobility or pathological root resorption
  • Children or parents who refused to participate in the study

Treatment and study plan

Pulpectomy

Procedure

Pulpectomy is performed in primary mandibular molars requiring endodontic treatment. Following administration of local anesthesia and rubber dam isolation, an access cavity is prepared and the root canals are identified. Working length is determined, followed by biomechanical preparation and irrigation of the root canals. The canals are then dried and obturated with a resorbable root canal filling material. The tooth is subsequently restored with an appropriate coronal restoration. Postoperative pain is assessed at predetermined intervals following treatment, and radiographic evaluation is performed to assess the quality of obturation.

Other names: Root canal treatment, Non-vital pulp therapy

Kedo-S Square rotary file

Device

Kedo S Square pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.

Other names: Kedo S square

Manual K files

Device

Manual K files were used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.

Other names: Hand files

Kedo-Nano Plus rotary file

Device

Kedo Nano Plus pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.

Other names: Kedo-Nano Plus

Primary outcomes

  1. To assess the quality of obturation between Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files after pulpectomy in primary mandibular molars

    Time frame: At the end of the pulpectomy procedure, immediately following obturation.

    Quality of obturation will be assessed radiographically following pulpectomy in primary mandibular molars. The obturation will be categorized as optimal fill, underfill, or overfill based on the extent of obturation material in relation to the radiographic apex. The outcome measure will be used to compare the effectiveness of the instrumentation techniques in achieving adequate root canal filling.

Secondary outcomes

  1. To evaluate the intensity of post-operative pain following pulpectomy performed using Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files at the interval of 6,12,24 and 48 hours postoperatively.

    Time frame: From completion of the pulpectomy procedure to 48 hours postoperatively, with assessments at 6, 12, 24, and 48 hours.

    Postoperative pain will be assessed following pulpectomy in primary mandibular molars using the Wong-Baker Faces Pain Rating Scale. Pain intensity will be recorded at 6, 12, 24, and 48 hours after completion of the procedure. The outcome measure will be used to compare the level and progression of postoperative pain among the study groups over time.

Sponsors and collaborators

Lead sponsor

Goa Dental College

Other Gov

Registry information

Official study title

Comparative Evaluation of Two Pediatric Rotary Files and Hand Files In Primary Mandibular Molars With Regard to Obturation Quality and Postoperative Pain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2026
Registry last updated
Jul 14, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.