Evaluating BioFlex Crowns for Children's Teeth
Evaluation of Bioflex Crowns Using the Hall Technique in Primary Molars (a Randomized Controlled Clinical Trial)
NA · Alexandria University · NCT06847646
This study is testing whether BioFlex crowns work better than traditional stainless steel crowns for kids' back teeth to see how well they hold up and how they affect jaw function over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 4 Years to 7 Years |
| Sex | All |
| Sponsor | Alexandria University (other) |
| Locations | 1 site (Alexandria) |
| Trial ID | NCT06847646 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of BioFlex crowns to traditional stainless steel crowns in treating primary molars using the Hall Technique. A total of 74 pediatric patients aged 4-8 years will be randomly assigned to receive either BioFlex crowns or stainless steel crowns. The study will assess clinical performance, radiographic success, and the impact on temporomandibular joint function over a 12-month follow-up period. Various health indices and satisfaction levels will also be evaluated to determine the overall effectiveness of the treatments.
Who should consider this trial
Good fit: Ideal candidates are children aged 4-8 years with specific types of carious lesions in primary molars.
Not a fit: Patients with irreversible pulpitis, abscesses, or other severe dental issues will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more effective option for pediatric dental crowns.
How similar studies have performed: While there is limited data on BioFlex crowns specifically, similar studies comparing crown types have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - Primary molar teeth with occlusal or occlusoproximal carious lesions into dentin (ICDAS codes: 3-5). Exclusion Criteria: Teeth will be excluded if they exhibit: * Clinical or radiographic signs of irreversible pulpitis. * Presence of fistula or abscess. * Spontaneous pain. * Pulp exposure. * Bruxism. * Pathologic mobility (identified by gently rocking the tooth buccolingually using tweezers).
Where this trial is running
Alexandria
- Faculty of Dentistry Alexandria University — Alexandria, Egypt (RECRUITING)
Study contacts
- Principal investigator: yousra ramadan, Ms — Alexandria University
- Study coordinator: Yousra Ramadan, Ms
- Email: yousra.ahmed.dent@alexu.edu.eg
- Phone: 00201227693601
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.
Conditions: BioFlex Crowns Using Hall Technique, BioFlex crowns, SSCs, Hall technique, TMJ function