NCT05748327

Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities

Randomized Controlled Clinical Trial (RCT) of the New Tooth-colored Restorative Material 'Cention Forte' (Ivoclar Vivadent) vs. 'Equia Forte HT' (GC) in Class-I/II Cavities

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Ivoclar Vivadent AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized-controlled clinical trial to investigate the success rate of two new tooth-colored restorative materials in class I and II cavities over 5 years according to FDI criteria scores (1, 2 and 3).

Detailed description

The primary outcome of the study is the SUCCESS RATE of restorations placed with both filling materials in class I and II cavities after 5 years of clinical service. A failure which leads to repair or replacement of the restoration can have esthetic (marginal staining, loss of anatomical form), functional (i.e. fracture of restoration, loss of retention) or biological reasons (i.e. secondary caries). A restoration is defined as a failure (no success) as soon as at least one FDI criterion is scored as 4 or 5.

Conditions

• Caries
• Defective Restorations

Interventions

Type	Name	Description
DEVICE	Alcasite restorative material	Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), conditioning with primer, mixing alcasite capsula, place restoration, polymerizing and finishing
DEVICE	Bulk fill glass hybrid restorative material	Cavity preparation, pulp protection (if necessary), placing matrix/ interdental wedge (if necessary), mixing bulk fill glass hybrid capsula, conditioning, place restoration, apply coating, polymerizing and finishing

Timeline

• Start date: 2022-11-22
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2023-02-28
• Last updated: 2024-03-29

Locations

1 site across 1 country: Belgium