NCT03175627

Clinical Performance of Posterior Composite Tooth Fillings in Adults

Clinical Investigation Of A Bulk Fill Composite In Class II Restorations In Adult Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Louisiana State University Health Sciences Center in New Orleans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a new tooth-colored composite material is effective for load-bearing dental fillings.

Detailed description

In this post-market prospective randomized controlled clinical trial, posterior class II restorations will be evaluated for their clinical performance. The study will investigate the survival and efficacy of a bulk-filled composite resin restorative material for a period of 2 years. The bulk fill composite will be used according to indication and applied in approximal two- or three-surface restorations in permanent teeth.

Conditions

• Dental Caries
• Dental Restoration Failure

Interventions

Type	Name	Description
DEVICE	Filtek One	Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique.
DEVICE	Filtek Z250	Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.

Timeline

• Start date: 2017-05-10
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2017-06-05
• Last updated: 2021-06-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study