NCT07523776

Vertical Dimension Changes After Bioflx vs Stainless Steel Crowns in Primary Molars

Vertical Dimension Changes and Mean Biting Force Following Bioflx Placement Over Pulp-treated Primary Molars Versus Stainless Steel Crowns: A Randomized Controlled Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

this randomized controlled trial will compare Bioflx crowns and stainless-steel crowns in children with pulp-treated primary molars. The study will evaluate changes in vertical dimension and mean biting force after crown placement and will also assess parental satisfaction with esthetics and treatment impact. Eligible children aged 6 to 9 years will be randomly assigned in a 1:1 ratio to receive either a Bioflx crown or a stainless-steel crown. Measurements will be taken at baseline, immediately after crown placement, at 1 week, and at 4 weeks.

Detailed description

Early childhood caries commonly affects primary molars and often requires full-coverage restoration after pulp therapy. Stainless steel crowns are widely used because of their durability and clinical success, but they may have limitations related to esthetics and acceptance. Bioflx crowns are a more esthetic and flexible alternative, but there is limited evidence comparing their functional performance with stainless steel crowns. This parallel randomized controlled trial will be conducted at the outpatient clinic of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University, Egypt. A total of 18 children with pulp-treated primary molars will be enrolled and randomly allocated in a 1:1 ratio to receive either a Bioflx crown or a stainless steel crown. The primary outcome is vertical dimension alteration measured in millimetres using a digital caliper. Secondary outcomes include mean biting force distribution measured by T-Scan digital occlusal analysis, parental satisfaction with esthetics, and parental satisfaction with treatment impact assessed by 5-point Likert scale questionnaires. Outcome measurements will be recorded at baseline, immediately after crown placement, at 1 week, and at 4 weeks, with parental satisfaction assessed at 4 weeks. The purpose of this study is to determine whether Bioflx crowns provide comparable or improved functional and esthetic outcomes compared with stainless steel crowns in pulp-treated primary molars.

Conditions

• Early Childhood Caries
• Dental Caries
• Pulp-Treated Primary Molars

Interventions

Type	Name	Description
DEVICE	Bioflx Crown	Aesthetic full-coverage pediatric crown used after pulp therapy of primary molars. The Bioflx crown will be selected according to tooth size, adapted following the study protocol, and cemented with resin-modified glass ionomer cement.
DEVICE	Stainless Steel Crown	Preformed stainless steel full-coverage pediatric crown used after pulp therapy of primary molars. The stainless steel crown will be selected according to tooth size, adapted following the study protocol, and cemented with resin-modified glass ionomer cement

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Egypt