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

July 10, 2026 updated by: Pooja Vilas More, Goa Dental College

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Goa
      • Bambolim, Goa, India, 403202
        • Goa Dental College and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Manual K-file group
Primary mandibular pulpectomy done by manual K- files
Procedure: Pulpectomy
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
Device: Manual K files
Manual K files were used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
Other Names:
  • Hand files
Experimental: Kedo-S Square rotary file group
Primary mandibular pulpectomy done by Kedo-S Square rotary file
Procedure: Pulpectomy
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
Device: Kedo-S Square rotary file
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
Experimental: Kedo-Nano Plus rotary file group
Primary mandibular pulpectomy done by Kedo-Nano Plus rotary file
Procedure: Pulpectomy
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
Device: Kedo-Nano Plus rotary file
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of the pulpectomy procedure, immediately following obturation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From completion of the pulpectomy procedure to 48 hours postoperatively, with assessments at 6, 12, 24, and 48 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goa Dental College

Investigators

  • Study Director: Paul Chalakkal, MDS, Goa Dental College and Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Actual)

January 2, 2026

Study Completion (Actual)

March 3, 2026

Study Registration Dates

First Submitted

June 25, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 14, 2026

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GDCH/IRB/VI-2024/RPN45-41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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