Active — Not RecruitingNot Applicable

Clinical Outcomes and Satisfaction of Stainless Steel vs Bioflx Crowns in Primary Molars

Vietnam25 participantsStarted 2025-08-01

Plain-language summary

The goal of this clinical trial is to learn if the Bioflx crown (a tooth-colored material) is as effective as the standard stainless steel crown for treating severely decayed baby back teeth in children aged 4 to 10 years old. The study also aims to evaluate parent and child satisfaction with these restorative options. The main questions it aims to answer are: 1. Is the Bioflx crown as effective as the stainless steel crown in terms of durability, staying in place, and protecting the tooth from new decay? 2. Does the Bioflx crown maintain better gum health and cause less wear on the opposing teeth compared to the stainless steel crown? Researchers will compare the Bioflx crown to the stainless steel crown to see which material works better to restore tooth function and health. Participants will: 1. Receive one Bioflx crown and one stainless steel crown on similar teeth on opposite sides of the mouth. 2. Visit the clinic for two separate appointments, spaced 1 to 2 weeks apart, to have the crowns placed. 3. Return for checkups at 3 months and 6 months so researchers can examine the health of the teeth and gums. 4. Answer questions about how happy they are with the appearance and feel of the crowns.

Who can participate

Age range

4 Years – 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: * Children with at least two carious primary molars located on both the right and left sides of the dental arch and indicated for crown placement * Children and their parents have ability to communicate in Vietnamese * Primary molars indicated for full-coverage crown restoration, including teeth with: * Multi-surface caries * Extensive caries or enamel-dentin defects * Interproximal caries * High risk of failure with other restorative materials * Teeth following pulpotomy or pulpectomy Exclusion Criteria: * Uncooperative children * Presence of psychiatric or neurological disorders affecting communication ability * Malocclusion (crossbite or scissors bite) * Having abnormal parafunctional habits * Teeth with root resorption exceeding one half of the root length

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

- Clincal outcomes: crown stability; bite discomfort; fit and color changes at the crown edge; crown shape; crown retention; crown wear; wear of the opposing tooth or crown - Oral hygiene and gum health around the crowns

Timeframe: - Crown stability, bite discomfort, fit and color at the crown margin, and crown shape were checked after crown placement, at 3 months, and at 6 months follow-up visits. Others were checked at 3, 6 months, except secondary caries was checked at 6 months

Trial details

NCT IDNCT07357402

SponsorPHAM LE ANH THY

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-01

View on ClinicalTrials.gov More Severely Decayed Primary Molars Requiring Full-Coverage Crowns trials