Using Bioflx Crowns for Treating Early Childhood Caries
Official title: Clinical Performance and Acceptance of Bioflx Crowns: a Randomized Controlled Clinical Trial
Run by Alexandria University · NCT06677983 · Data updated 2026-11-12
This study is testing a new type of dental crown for kids with early childhood cavities to see if it works well and is liked by both children and dentists compared to the usual stainless steel crowns.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 8 Years |
| Sex | All |
| Enrollment | 62 (estimated) |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | May 1, 2025 |
| Study ends | July 1, 2025 |
| Registry record updated | November 7, 2024 |
| Trial ID | NCT06677983 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children with primary molars that require full coverage due to caries.
✕Probably not a fit
Patients with systemic diseases or severe dental conditions such as irreversible pulpitis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the clinical performance and acceptance of Bioflx crowns in pediatric patients with early childhood caries. The Bioflx crown is designed to combine the aesthetic benefits of zirconia with the durability of stainless steel, providing a less invasive option for full coverage of primary molars. The study aims to assess how well these crowns perform in real-world clinical settings and how they are accepted by both clinicians and patients. Participants will be children who require full coverage for their primary molars, and the study will compare the outcomes with traditional stainless steel crowns.
Why it matters
Potential benefit: If successful, this approach could provide a more aesthetically pleasing and effective treatment option for young children with dental caries.
How similar studies have gone: While the specific Bioflx crown has not been widely tested, similar approaches using aesthetic crowns have shown promise in improving treatment outcomes in pediatric dentistry.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * A child with primary molars is indicated for full coverage. Exclusion Criteria: * Children with any systemic disease * Clinical or radiographic signs/symptoms of irreversible pulpitis as abscess, fistula, spontaneous pain, mobility, furcation involvement, internal or external root resorption * Children cooperation (1,2) according to Frankl scale * Parents are unwilling to enroll their children in study
Where it's running
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Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt
Alexandria, Egypt Recruiting
Study contacts
- Study coordinator: Rabab K ElGhandour, PhD
- Email: rabab.elghandour@pua.edu.eg
- Phone: 01222469150
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.