CompletedNot Applicable

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

India60 participantsStarted 2025-01-15

Plain-language 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.

Who can participate

Age range

5 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07702877

SponsorGoa Dental College

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-01-02

View on ClinicalTrials.gov More Pulpectomy trials