NCT07702877

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

June 25, 2026

Last Update Submit

July 10, 2026

Conditions

PulpectomyPrimary Teeth Indicated for Pulp TherapyMandibular Molar Teeth With Symptomatic Irreversible Pulpitis

Keywords

PulpectomyPrimary mandibular molars indicated for pulpectomypediatric rotary files

Outcome Measures

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

    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 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.

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

Study Arms (3)

Manual K-file group

EXPERIMENTAL

Primary mandibular pulpectomy done by manual K- files

Procedure: PulpectomyDevice: Manual K files

Kedo-S Square rotary file group

EXPERIMENTAL

Primary mandibular pulpectomy done by Kedo-S Square rotary file

Procedure: PulpectomyDevice: Kedo-S Square rotary file

Kedo-Nano Plus rotary file group

EXPERIMENTAL

Primary mandibular pulpectomy done by Kedo-Nano Plus rotary file

Procedure: PulpectomyDevice: Kedo-Nano Plus rotary file

Interventions

PulpectomyPROCEDURE

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.

Also known as: Root canal treatment, Non-vital pulp therapy
Kedo-Nano Plus rotary file groupKedo-S Square rotary file groupManual K-file group
Kedo-S Square rotary fileDEVICE

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

Also known as: Kedo S square
Kedo-S Square rotary file group
Manual K filesDEVICE

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

Also known as: Hand files
Manual K-file group
Kedo-Nano Plus rotary fileDEVICE

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

Also known as: Kedo-Nano Plus
Kedo-Nano Plus rotary file group

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goa Dental College and Hospital

Bambolim, Goa, 403202, India

Location

MeSH Terms

Interventions

Pulpectomy

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Officials

  • Paul Chalakkal, MDS

    Goa Dental College and Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior resident

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 14, 2026

Study Start

January 15, 2025

Primary Completion

January 2, 2026

Study Completion

March 3, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Locations

IN(1)