NCT06713330

Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth

A 36-Month Prospective Randomized Clinical Pilot Trial Comparing Stainless Steel Crowns with Prefabricated Resin Crowns in Primary Molar Teeth

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Accepted

Summary

The main reason for this research study is to learn more about a new flexible white dental crown (BioFLX) by comparing it to an existing flexible metal crown (Stainless Steel Crown). It is of interest to see if this new white crown is clinically equivalent to the existing silver crown that is mainly used in pediatric dentistry. A potential participant for this study would have cavities that require a crown, a type of filling that covers the entire tooth, and recommended dental work be done under general anesthesia.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	BioFLX crown	Device: BioFLX crown
DEVICE	3M Stainless Steel Crown	3M Stainless Steel Crown

Timeline

• Start date: 2024-05-17
• Primary completion: 2025-05-15
• Completion: 2025-05-15
• First posted: 2024-12-03
• Last updated: 2024-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study