NCT07212660

A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth

A Multi-center, Randomized-controlled, 12-month, Split-mouth, Non-inferiority Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy With a Flowable Bulk Fill Composite in Class I and II Deciduous Teeth

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Ivoclar Vivadent AG · Industry
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this clinical investigation is to assess the clinical performance and safety of composite restorations cured with fast curing mode (5 seconds with 2000 mW/cm²) in primary molars.

Detailed description

Dental interventions in young children are challenging due to limited compliance and anxiety. Moisture control during the placement of resin composite fillings is particularly difficult, as children need to remain calm. Reducing treatment time benefits both children and dentists. The planned clinical investigation aims to evaluate the clinical performance and safety of posterior restorations on primary teeth using a flowable composite with a fast curing mode (5 seconds, 2000 mW/cm²) compared to a conventional curing mode (10 seconds, 1200 mW/cm²).

Conditions

• Dental Caries
• Insufficient Dental Filling

Interventions

Type	Name	Description
DEVICE	Fast curing mode	Composite restoration is cured with Turbo mode (5 seconds with 2000 mW/cm²).
DEVICE	Conventional curing mode	Composite restoration is cured with High mode (10 seconds with 1200 mW/cm²).

Timeline

• Start date: 2025-12-18
• Primary completion: 2026-11-01
• Completion: 2027-10-01
• First posted: 2025-10-08
• Last updated: 2026-03-25

Locations

2 sites across 1 country: Switzerland