NCT06677983

Clinical Performance and Acceptance of Bioflx Crowns

Clinical Performance and Acceptance of Bioflx Crowns: a Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Hams Hamed Abdelrahman · Academic / Other
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

Treating pediatric patients with early childhood caries can be challenging. For clinicians, managing a young child while ensuring high-quality treatment is difficult. It is essential to have the best equipment and materials available. Today, aesthetics are crucial in managing decayed teeth, with zirconia crowns often preferred for their visual appeal, although they require substantial preparation. The newly developed Bioflx crown, combining stainless steel and zirconia properties, offers an alternative solution.

Conditions

• Caries

Interventions

Type	Name	Description
OTHER	Bioflex Crowns	A preformed crown of similar size will be selected. Tooth preparation will be done using a tapered diamond bur to reduce the occlusal surface, including the central groove, by 1-1.5 mm. The proximal surfaces will be prepared by approximately 0.5 mm to clear the contact area.
OTHER	Stainless steel crown	An appropriately sized preformed stainless-steel crown will be selected. Tooth preparation will involve using a tapered bur ) to reduce the occlusal surface by 1 to 1.5 mm, with interproximal reduction made on the mesial and distal sides. The selected crown size will be checked, and a trial fit will be conducted prior to cementation. Crimping pliers will be used, and the crown will be cemented with Type 1 glass ionomer cement. Any excess cement will be removed, and proper occlusion will be verified.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-05-01
• Completion: 2025-07-01
• First posted: 2024-11-07
• Last updated: 2024-11-07

Locations

1 site across 1 country: Egypt