Zirconia and Bioflx Crowns for Primary Anterior Teeth (NCT07691905) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Zirconia and Bioflx Crowns for Primary Anterior Teeth
Vietnam120 participantsStarted 2026-01-04
Plain-language summary
This parallel-group randomized controlled trial will compare the clinical performance of prefabricated zirconia and Bioflx crowns for restoring primary maxillary anterior teeth in children aged 3 to 5 years. Eligible participants will be randomly assigned in a 1:1 ratio to receive either a zirconia crown or a Bioflx crown.
Clinical outcomes will be assessed at 3, 6, and 12 months after crown placement. Evaluations will include gingival health, plaque accumulation, wear of the opposing tooth, crown retention, and clinical symptoms of the treated tooth. Parent satisfaction with the esthetic outcome will also be evaluated.
The study aims to provide comparative clinical evidence on the effectiveness of zirconia and Bioflx crowns for restoration of primary maxillary anterior teeth.
Who can participate
Age range
3 Years – 5 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 aged 3 to 5 years.
* Children requiring full-coverage restoration of one or more primary maxillary anterior teeth.
* Presence of an opposing tooth.
* Target tooth with at least two carious surfaces, caries involving the incisal edge, or discoloration associated with hypomineralization.
* Written informed consent from a parent or legal guardian and willingness to comply with treatment and follow-up visits.
Exclusion Criteria:
* Allergy to Fuji IX Extra glass ionomer cement.
* Acute systemic disease.
* Crowded teeth affecting crown placement.
* Pulp exposure before treatment.
* Inadequate remaining clinical crown structure after tooth preparation.
* Absence of an opposing tooth.
* Bruxism or deep bite.
* Tooth close to exfoliation or root resorption exceeding one-half of the root length.
* Caries limited to a single surface without proximal involvement.
* History of trauma affecting the target tooth.
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
1
Gingival index
Timeframe: 3, 6, and 12 months after crown placement
2
Fluorescent Plaque Index
Timeframe: 3, 6, and 12 months after crown placement
3
Opposing Tooth Wear
Timeframe: 3, 6, and 12 months after crown placement
4
Crown Retention
Timeframe: 3, 6, and 12 months after crown placement
5
Clinical Status of Crowned Teeth
Timeframe: 3, 6, and 12 months after crown placement