CompletedNot Applicable

Comparative Evaluation of Clinical Success of BIOFLX Crowns and SSC in Primary Molars

India36 participantsStarted 2025-06-22

Plain-language summary

Although Stainless steel crowns (SSC) are the gold standard treatment modality for multi-surface carious lesion in paediatric patients, the quest for metal free, aesthetic restoration with comparable features that of SSC still continues. This research compares the clinical effectiveness of Bioflx crowns (Kids-e-dental)TM to the "gold standard" Stainless Steel crowns (Rainbow crowns)TM

Who can participate

Age range

10 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: * • At least two primary molars (contra-lateral or opposing side) needing full coverage restoration. * Consent of patient/legal guardian of the child * Cooperative behaviour based on Frankel behaviour rating 3 or 4 (positive or definitely positive) Exclusion Criteria: * • Parent not willing to give consent. * Child with special health care needs * Uncooperative child based on Frankel rating1or 2 (definitely negative or negative) * History of Ni-Cr allergy

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

US Public Health Service (USPHS) modified criteria

Timeframe: 1st month, 3rd month, 6th month and 12 th month

Trial details

NCT IDNCT07465211

Sponsorsatish vishwanathaiah

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-09-25

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