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

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.

Conditions

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

Interventions

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.

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.

DEVICE

Manual K files

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

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.

Sponsors & Collaborators

• Goa Dental College

  lead OTHER_GOV

Principal Investigators

• Paul Chalakkal, MDS · Goa Dental College and Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

5 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-15

Primary Completion

2026-01-02

Completion

2026-03-03

Countries

• India

Study Locations