Comparing different types of crowns for children's molars
Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars: A Randomized Controlled Clinical Trial
NA · Mansoura University · NCT06450093
This study is testing which type of crown—BioFlx, Zirconia, or Stainless Steel—works best for fixing children's back teeth between the ages of 4 and 7.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 4 Years to 7 Years |
| Sex | All |
| Sponsor | Mansoura University (other) |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT06450093 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation aims to compare the effectiveness of BioFlx, Zirconia, and Stainless Steel crowns in restoring primary molars in children aged 4 to 7 years. The study will involve 51 children, who will be randomly assigned to receive one of the three types of crowns. Clinical assessments will focus on crown retention, color stability, secondary caries, periodontal changes, and wear of opposing teeth over an 18-month period. The trial will adhere to rigorous reporting standards to ensure reliability and validity of the findings.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 7 years with a carious lower primary molar that requires crown restoration.
Not a fit: Patients with systemic diseases, poor oral hygiene, or teeth that are not suitable for restoration will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective crown material for restoring children's primary molars, leading to better dental outcomes.
How similar studies have performed: Previous studies have shown varying success with different crown materials in pediatric dentistry, making this evaluation both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children who are free from any systemic disease. * Children with a carious lower primary molar indicated for crown restoration. * Teeth with an intact antagonist and neighboring primary molar. * Cooperative children with scores 1 and 2 (positive or definitely positive) according to Frankl's behavior rating scale. Exclusion Criteria: * Children with extremely poor oral hygiene. * Teeth showing radiographical furcation involvement or root resorption. * Children with para-functional habits, bruxism, or deep bite. * Teeth with inadequate non-restorable crown structure.
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Faculty of Dentistry, Mansoura University. — Al Mansurah, Dakahlia Governorate, Egypt (RECRUITING)
Study contacts
- Study coordinator: Heba 0. Elbadry
- Email: Hebaaelbadry@mans.edu.eg
- Phone: +201116121999
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: Dental Restoration, Bioflx Crowns, Wear, Zirconia Crowns, stainless steel Crowns, periodontal changes