Using Bioflx Crowns for Treating Early Childhood Caries
Clinical Performance and Acceptance of Bioflx Crowns: a Randomized Controlled Clinical Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 4 Years to 8 Years |
| Sex | All |
| Sponsor | Alexandria University Academic / other |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT06677983 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children with primary molars that require full coverage due to caries.
Not a fit: Patients with systemic diseases or severe dental conditions such as irreversible pulpitis will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Alexandria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.